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The present study was aimed to formulate and evaluate Fast Dissolving Sublingual Tablets of Ivabr... more The present study was aimed to formulate and evaluate Fast Dissolving Sublingual Tablets of Ivabradine Hydrochloride, a selective If current inhibitor to reduce ischemic condition in Stable Angina. Efficacy of sublingual administration, higher permeability of drug and improvement in bioavailability achievement for drug were the factors that lead to the development of the present work. Compatibility studies of drug and polymer were performed by FTIR and demonstrated no interaction between drug and excipients. Tablets were prepared by direct compression using different concentration of Croscarmellose sodium and Crospovidone. Pre-compression parameters for blend were in the range. Prepared tablets were evaluated for disintegration time, wetting time, Water absorption ratio, %CDR and Ex-vivo permeability study. Formulation F6 (3% CCS, 4.5% CP) was found to be the optimized and showed disintegration time of 25 sec. In vitro drug release was found within 7 minutes and maximum relative permeability from F6 was up to 21 minutes. Dosage form also showed better stability criteria. From the results it was concluded that prepared FDTs executed faster release of IBH with improved characteristic
Pantoprazole sodium and ondansetron hydrochloride are commonly prescribed for the treatment of ga... more Pantoprazole sodium and ondansetron hydrochloride are commonly prescribed for the treatment of gastric and duodenal ulcer associated with vomiting. Both the drugs having short biological half-life, so it leads frequent administration which may lead to patient incompliance. Further the pantoprazole Na is acid labile molecules and having irritation effect to stomach mucosa, so it needs to be given in the form of enteric formulation. While in case of ondansetron HCl have narrow therapeutic window in the stomach hence to prepare gastro-retentive formulation which offers advantages like better patient compliance and would lower the total cost of therapy. For the floating layer, influence of polymers and NaHCO3 with the application of 32 factorial design to optimization, for improving the sustain release of ondansetron HCl. It was prepared by wet granulation method and evaluated this layer using in vitro buoyancy and in vitro drug release study. For the enteric layer, influence of polymers and solvent system was preventing the drug release in the stomach environment with targeting at duodenal ulcers. It was prepared by intra-granulation method and evaluating by conducting in vitro study.
A Microsponge delivery system (MDS) is “Patented, highly cross-linked, porous, polymeric microsph... more A Microsponge delivery system (MDS) is “Patented, highly cross-linked, porous, polymeric microspheres polymeric system consisting of porous microspheres that can entrap wide range of actives. It is a unique technology for the controlled release consists of micro porous beads, typically 10-25 microns in diameter, loaded with active agent. Aceclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking the action of cyclooxygenase. The pharmacokinetic profile and intracellular metabolism of Aceclofenac provide a strong rationale for the development of a sustained release formulation. A Microsponge based drug delivery system of Aceclofenac was planned for development and characterization for in vitro performances. The effect of Eudragit RS100 and PVA on formulation of microsponges was determined by using 32 factorial design. Aceclofenac Microsponge were prepared using an Quasi emulsion solvent diffusion method by adding an organic internal phase containing Aceclofenac, Eudragit RS100, Tri ethyl citrate and solvent into a stirred aqueous phase containing polyvinyl alcohol.
Fast dissolving films have become popular as a new delivery system because they are easy to admin... more Fast dissolving films have become popular as a new delivery system because they are easy to administer and sudden onset of drug action is possible as the films are taken through the sublingual route. In present study Zolmitriptan fast dissolving sublingual films were prepared which allow fast, reproducible drug dissolution in the oral cavity, thus bypassing first pass metabolism to provide rapid onset of drug action. The fast dissolving films were prepared by solvent casting method. Low viscosity grade of hydroxylpropyl methylcellulose (HPMC E5) and maltodextrin were used as film forming polymer due to their hydrophilic nature. Proposed combination provides acceptable dissolving criteria owing to HPMC E5 and better mechanical properties due to maltodextrin. Propylene glycol, citric acid, mannitol and mango flavour were used as a plasticizer, saliva stimulating agent, sweetener and flavouring agent respectively. Drug-excipients compatibility study was done using FT-IR spectroscopy. The prepared films were evaluated for thickness, weight variation, disintegration time, surface pH, folding endurance, drug content, in vitro dissolution, tensile strength and % elongation.
The present work introduces a new tablet system for sublingual administration in which the tablet... more The present work introduces a new tablet system for sublingual administration in which the tablet is based on interactive mixtures of components, consisting of carrier particles partially covered by fine dry particles of the drug, in this case Rabeprazole sodium. In the interests of increasing retention of the drug at the site of absorption in the oral cavity, a bioadhesive component was also added to the carrier particles. With this approach, it is possible to obtain rapid dissolution in combination with bioadhesive retention of the drug in the oral cavity. Rabeprazole sodium is an anti ulcer drug having oral bioavailability 52% due to hepatic first pass metabolism. This work aims to avoid degradation of drug in acidic environment of stomach. In this study, Rabeprazole sodium sublingual tablets were prepared by direct compression method using different bioadhesive polymers such as HPMC K4M and chitosan and sodium starch glycolate as a superdisintegrant. The effect of different concentration of polymers and superdisintegrating agents was measured by applying Box-Behnken design.
In the present study, formulation of Fast dissolving film containing antihistaminic drug Deslorat... more In the present study, formulation of Fast dissolving film containing antihistaminic drug Desloratadine was designed to achieve immediate release of drug from the dosage form, to increase therapeutic efficacy and to improve patient compliance in case of allergy. The combination of drug with suitable polymers such as HPMC E-5 and HPMC E-15 helps in providing quick onset of action. The basic aim of this work is to produce immediate release action of drug from the film. Fast dissolving film was prepared by solvent casting method using PEG 400 as plasticizer. A full factorial design was used to study the effect of HPMC E-5 and HPMC E-15 on disintegration time, thickness and folding endurance of the film. The responses were analyzed using ANOVA and by the polynomial equation. All the formulations were then evaluated for disintegration time, weight variation, and drug content and dissolution studies. Stability study shows that there was no significant change in physical appearance, disintegration time, thickness, drug content and In vitro drug release of the formulation. Fast dissolving film is an innovative concept for quick release of the drug.
Novel drug delivery systems constitute the main stay of pharmaceutical research and development. ... more Novel drug delivery systems constitute the main stay of pharmaceutical research and development. Various novel drug delivery systems exists in the pharmaceuticals and one of such delivery system is nanoparticles. Nanoparticles are monolithic systems in which the drug is adsorbed, dissolved, or dispersed throughout the matrix. There are various forms of nanoparticles, out of which a newer and novel system is buckyballs. Buckyball is a member of a class of carbon structures called fullerenes. Hence they are also known as Buckminsterfullerene or fullerene. They are discovered by British scientist Harry Kroto in 1985 and the arrangement of the atoms resembled the shape of the geodesic domes invented by architect Buckminster Fuller and hence the nanostructure is named as Buckyballs. Buckyballs are made of 60 carbon atoms formed in the shape of a hollow ball and are similar in structure to graphite, which is composed of a sheet of linked hexagonal rings but they contain pentagonal (or sometimes heptagonal) rings that prevent the sheet from being planar.Various experimental studies have been done, still going on to prove it to be advantageous and perfectly fit for the pharmaceutical field.
Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sne... more Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sneezing, runny nose and itching that a patient suffers with an allergic attack or an infection. It has poor solubility in water. Therefore, the solubility and drug release were enhanced using the solid dispersion technique and fast dissolving tablet were formulated. Solid dispersion prepared using Poloxamer 407, PEG 6000 and urea. The solid dispersion were evaluated for saturation solubility, drug content and in vitro dissolution study and it was characterized using FT-IR, X-RD, SEM and DSC study. The fast dissolving tablets of loratadine was formulated using crospovidone and crosscarmelose sodium by direct compression method. The tablets were evaluated for thickness, hardness, weight variation, friability, disintegration time and % in vitro drug release. A 32 factorial design was used to study the effect of Loratadine: Poloxamer 407 and crospovidone on disintegration time and % in vitro drug release. The responses were analyzed using ANOVA. The obtained model was validated & optimized formulation was prepared as suggested by the software.
Nanoparticles hold tremendous potential as an effective drug delivery system. In this overview we... more Nanoparticles hold tremendous potential as an effective drug delivery system. In this overview we discussed recent developments in nanotechnology for drug delivery. To overcome the problems of gene and drug delivery, nanotechnology has gained interest in recent years. Nanosystems with different compositions and biological properties have been extensively investigated for drug and gene delivery applications. To achieve efficient drug delivery it is important to understand the interactions of nanomaterials with the biological environment, targeting cell-surface receptors, drug release, multiple drug administration, stability of therapeutic agents and molecular mechanisms of cell signaling involved in pathobiology of the disease under consideration. Several anti-cancer drugs including paclitaxel, doxorubicin, 5-fluorouracil and dexamethasone have been successfully formulated using nanomaterials. Quantom dots, chitosan, Polylactic/glycolic acid (PLGA) and PLGA based nanoparticles have also been used for in vitro RNAi delivery. The use of nanomaterials including peptide-based nanotubes is a new approach to control disease progression.
Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sne... more Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sneezing, runny nose and itching that a patient suffers with an allergic attack or an infection. It has poor solubility in water. Therefore, the solubility and drug release were enhanced using the solid dispersion technique and fast dissolving tablet were formulated. Solid dispersion prepared using Poloxamer 407, PEG 6000 and urea. The solid dispersion were evaluated for saturation solubility, drug content and in vitro dissolution study and it was characterized using FT-IR, X-RD, SEM and DSC study. The fast dissolving tablets of loratadine was formulated using crospovidone and crosscarmelose sodium by direct compression method. The tablets were evaluated for thickness, hardness, weight variation, friability, disintegration time and % in vitro drug release. A 32 factorial design was used to study the effect of Loratadine: Poloxamer 407 and crospovidone on disintegration time and % in vitro drug release. The responses were analyzed using ANOVA. The obtained model was validated & optimized formulation was prepared as suggested by the software.
Nanoparticles are solid colloidal particles ranging in size from 10-1000 nm. They can be used as ... more Nanoparticles are solid colloidal particles ranging in size from 10-1000 nm. They can be used as drug carrier with the drug encapsulated, dissolved, adsorbed or covalently attached. Nanoparticles are able to interact and remain associated to the ocular mucosa for extended periods of time, thus being promising carriers for enhancing and controlling the release of drugs to the ocular surface. Current studies are aimed at investigating in further detail how the interaction and internalization of these particles occurs and their toxicity following repeated administration. With breakthroughs in biotechnology, newer and more potent peptide and protein drugs are emerging in the market. The majority of these polypeptides require special delivery systems. However, since most of these compounds are very potent, require low doses, and are well absorbed from the mucous membrane; their delivery via the ocular route may be viable. However, one of the principal problems in the ocular delivery of peptide and protein drugs is that of relatively low bioavailability to the ocular tissues. This problem may be circumvented by the use of penetration enhancers.
Quality, safety and effectiveness must be built into the product. This requires careful attention... more Quality, safety and effectiveness must be built into the product. This requires careful attention to a number of factors such as the selection of quality materials/components, product and process design, control of processes, in-process control, and end-product testing. Due to the complexity of the drug products, routine end-product testing alone is not sufficient due to several reasons. Furthermore, quality cannot be tested into the finished drug product but rather be built in the manufacturing processes and these processes should be controlled in order that the finished product meets all quality specifications. A careful design and validation of systems and process controls can establish a high degree of confidence that all lots or batches produced will meet their intended specifications.The Validation Master Plan should be a summary document and should therefore be brief, concise and clear. It should not repeat information documented elsewhere but should refer to existing documents such as policy documents, SOP's and validation protocols and reports. The validation master plan should provide an overview of entire validation operation, its organizational structure & its content.
In the present study, formulation of multi-compartment dosage form containing soft gelatin capsul... more In the present study, formulation of multi-compartment dosage form containing soft gelatin capsule of Nifedipine, granules of Losartan potassium and fast disintegrating tablet of Hydrochlorothiazide was designed to achieve immediate release of drug from the dosage form, to increase therapeutic efficacy and to improve patient compliance in case of hypertension. Triple combination of antihypertensive drugs induces superior reduction in blood pressure as compared to conventional dosage form. The basic aim of this work is to produce immediate release action of drug from the hard gelatin capsule containing soft gelatin capsule of Nifedipine, granules of Losartan potassium and fast disintegrating tablet of Hydrochlorothiazide. Soft gelatin capsule was prepared by encapsulation method using propylene glycol and PEG 400 as solubilizing agents. The granules were prepared by wet granulation method using PVP K30 as binder. The fast disintegrating tablets were prepared by direct compression method using croscarmellose sodium and crospovidone as super disintegrating agents. Multi-compartment dosage form was considered as optimized formulation for immediate release of antihypertensive drugs.
Capsule dosage form is most convenient and relevant dosage form. Soft gels are becoming a popular... more Capsule dosage form is most convenient and relevant dosage form. Soft gels are becoming a popular dosage form for the administration of liquids, suspensions, pastes and dry powders. Soft gels are easy to swallow and have the ability to mask odors and unpleasant taste. They have an elegant appearance, readily dissolve in the gastric juices of the digestive tract and they may enhance the bioavailability of the active ingredients. Nifedipine, a calcium-channel blocking agent, is widely used in the treatment of angina pectoris and systemic hypertension. Half life of the drug is comparatively short 2 hours and Nifedipine is completely insoluble in water. Therefore, it has been generally accepted that soft gelatin capsule (Softgels) formulations are most efficient for routine hypertension therapy with Nifedipine. The main objective of the study was to formulate and evaluate soft gelatin capsule dosage form of Nifedipine used in the treatment of hypertension using oily polymers like propylene glycol and PEG 400 to enhance the solubility of Nifedipine.
Bilayer tablet is new era for successful development of controlled release formulation along with... more Bilayer tablet is new era for successful development of controlled release formulation along with various features to provide successful drug delivery system. Bilayer tablets can be a primary option to avoid chemical incompatibilities between API by physical separation and to enable the development of different drug release profiles. The manufacture of bilayer tablets produced by sequential compaction of loose powder layers has become of increased interest within the pharmaceutical industry due to the tailored release profiles of active ingredients that may be obtained. Bilayer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet. The immediate release layer of bilayer tablet has worked as the loading dose and the sustained release layer has maintained therapeutic plasma drug concentration for prolonged time. Using a modified tablet press may therefore be the best approach in producing a quality bilayer tablet under GMP conditions, especially when high production output is required.
Oral drug delivery systems being the most cost-effective and leads the worldwide drug delivery ma... more Oral drug delivery systems being the most cost-effective and leads the worldwide drug delivery market. The major problem in oral drug system is low and erratic bioavailability, which mainly results from poor aqueous solubility. This may lead to high inter and intra subject variability, lack of dose proportionality and therapeutic failure. For the improvement of bio-availability of drugs with such properties presents one of the greatest challenges in drug formulations. Various technological strategies are reported in the literature including solid dispersions, cyclodextrines complex formation and micronization. Including these approaches self-emulsifying drug delivery system (SEDDS) has gained more attention for enhancement of oral bio-availability with reduction in dose. SEDDS are isotropic mixtures of oil, surfactants, solvents and co-solvents/surfactants. For lipophilic drugs, which have dissolution rate-limited absorption, SEDDS may be a promising strategy to improve the rate and extent of oral absorption. This book explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.
Recent advances in novel drug delivery system aims to enhance safety and efficacy of drug molecul... more Recent advances in novel drug delivery system aims to enhance safety and efficacy of drug molecule by formulating a convenient dosage form for administration and to achieve better patient compliance. One such approach is fast dissolving tablets (FDT) of Phenylephrine Hydrochloride, a selective α1 adrenergic receptor antagonist, used for nasal decongestant and producing mydriasis effect. In present work an attempt has been made by formulating fast dissolving tablets of Phenylephrine Hydrochloride by superdisintegrants addition method using croscarmellose sodium, crospovidone and sodium starch glycolate. A total of 10 batches were prepared by using various combination and concentration of superdisintegrants and evaluated for general appearance and physical parameters, drug content, in vitro disintegration, in vitro dispersion, in vitro drug release studies, kinetic studies and stability studies. Amongst all the formulations F2 and F9 were found to be better formulations which include single superdisintegrants and combination of superdisintegrants. Finally it was concluded that FDT of Phenylephrine Hydrochloride will be used as a novel drug dosage form for pediatrics and geriatrics.
In ayurveda, most of the drugs were given in the form of powder, kasaya (decoction form) or bhasm... more In ayurveda, most of the drugs were given in the form of powder, kasaya (decoction form) or bhasma. In present study, topical formulations were prepared for local effect. The main objective of present study was to develop semisolid dosage form of Panchatikta extract using emulsifying ointment BP and Carbopol-941 as a base. The work was focused on reducing the total dosage size and incorporating more amounts of active principles in the dosage form. All formulations were evaluated for pH, spreadibility, viscosity and antimicrobial activity. Emulsifying ointment BP base was found to the best as compared to that of gel base. The antimicrobial activity was carried out using E. coli and S. aureus. The results showed that zone of inhibition of formulation FIe prepared by emulsifying ointment base was found to be 18.3 for S. aureus and 17.4 for E. coli, pH was 6.4 and spreadibility was 4.06 cm. The stability data indicated that the formulation was a stable preparation.
The naturally occurring polyphenol resveratrol (RES) has attracted increasing attention in recent... more The naturally occurring polyphenol resveratrol (RES) has attracted increasing attention in recent years due to its antioxidant, anti-inflammatory, and anticancer activity. However, resveratrol's promising potential as a nutraceutical is hindered by its poor aqueous solubility, which limits its biological activity. Here we show that encapsulating resveratrol in colloidal mesoporous silica nanoparticles (MCM-48-RES) enhances its saturated solubility by ∼95% and increases its in vitro release kinetics compared to pure resveratrol. MCM-48-RES showed high loading capacity (20% w/w) and excellent encapsulation efficiency (100%). When tested against HT-29 and LS147T colon cancer cell lines, MCM-48-RES-mediated in vitro cell death was higher than that of pure resveratrol, mediated via the PARP and cIAP1 pathways. Finally, MCM-48-RES treatment also inhibited lipopolysaccharide-induced NF-κB activation in RAW264.7 cells, demonstrating improved anti-inflammatory activity. More broadly, our observations demonstrate the potential of colloidal mesoporous silica nanoparticles as next generation delivery carriers for hydrophobic nutraceuticals.
The present study was aimed to formulate and evaluate Fast Dissolving Sublingual Tablets of Ivabr... more The present study was aimed to formulate and evaluate Fast Dissolving Sublingual Tablets of Ivabradine Hydrochloride, a selective If current inhibitor to reduce ischemic condition in Stable Angina. Efficacy of sublingual administration, higher permeability of drug and improvement in bioavailability achievement for drug were the factors that lead to the development of the present work. Compatibility studies of drug and polymer were performed by FTIR and demonstrated no interaction between drug and excipients. Tablets were prepared by direct compression using different concentration of Croscarmellose sodium and Crospovidone. Pre-compression parameters for blend were in the range. Prepared tablets were evaluated for disintegration time, wetting time, Water absorption ratio, %CDR and Ex-vivo permeability study. Formulation F6 (3% CCS, 4.5% CP) was found to be the optimized and showed disintegration time of 25 sec. In vitro drug release was found within 7 minutes and maximum relative permeability from F6 was up to 21 minutes. Dosage form also showed better stability criteria. From the results it was concluded that prepared FDTs executed faster release of IBH with improved characteristic
Pantoprazole sodium and ondansetron hydrochloride are commonly prescribed for the treatment of ga... more Pantoprazole sodium and ondansetron hydrochloride are commonly prescribed for the treatment of gastric and duodenal ulcer associated with vomiting. Both the drugs having short biological half-life, so it leads frequent administration which may lead to patient incompliance. Further the pantoprazole Na is acid labile molecules and having irritation effect to stomach mucosa, so it needs to be given in the form of enteric formulation. While in case of ondansetron HCl have narrow therapeutic window in the stomach hence to prepare gastro-retentive formulation which offers advantages like better patient compliance and would lower the total cost of therapy. For the floating layer, influence of polymers and NaHCO3 with the application of 32 factorial design to optimization, for improving the sustain release of ondansetron HCl. It was prepared by wet granulation method and evaluated this layer using in vitro buoyancy and in vitro drug release study. For the enteric layer, influence of polymers and solvent system was preventing the drug release in the stomach environment with targeting at duodenal ulcers. It was prepared by intra-granulation method and evaluating by conducting in vitro study.
A Microsponge delivery system (MDS) is “Patented, highly cross-linked, porous, polymeric microsph... more A Microsponge delivery system (MDS) is “Patented, highly cross-linked, porous, polymeric microspheres polymeric system consisting of porous microspheres that can entrap wide range of actives. It is a unique technology for the controlled release consists of micro porous beads, typically 10-25 microns in diameter, loaded with active agent. Aceclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking the action of cyclooxygenase. The pharmacokinetic profile and intracellular metabolism of Aceclofenac provide a strong rationale for the development of a sustained release formulation. A Microsponge based drug delivery system of Aceclofenac was planned for development and characterization for in vitro performances. The effect of Eudragit RS100 and PVA on formulation of microsponges was determined by using 32 factorial design. Aceclofenac Microsponge were prepared using an Quasi emulsion solvent diffusion method by adding an organic internal phase containing Aceclofenac, Eudragit RS100, Tri ethyl citrate and solvent into a stirred aqueous phase containing polyvinyl alcohol.
Fast dissolving films have become popular as a new delivery system because they are easy to admin... more Fast dissolving films have become popular as a new delivery system because they are easy to administer and sudden onset of drug action is possible as the films are taken through the sublingual route. In present study Zolmitriptan fast dissolving sublingual films were prepared which allow fast, reproducible drug dissolution in the oral cavity, thus bypassing first pass metabolism to provide rapid onset of drug action. The fast dissolving films were prepared by solvent casting method. Low viscosity grade of hydroxylpropyl methylcellulose (HPMC E5) and maltodextrin were used as film forming polymer due to their hydrophilic nature. Proposed combination provides acceptable dissolving criteria owing to HPMC E5 and better mechanical properties due to maltodextrin. Propylene glycol, citric acid, mannitol and mango flavour were used as a plasticizer, saliva stimulating agent, sweetener and flavouring agent respectively. Drug-excipients compatibility study was done using FT-IR spectroscopy. The prepared films were evaluated for thickness, weight variation, disintegration time, surface pH, folding endurance, drug content, in vitro dissolution, tensile strength and % elongation.
The present work introduces a new tablet system for sublingual administration in which the tablet... more The present work introduces a new tablet system for sublingual administration in which the tablet is based on interactive mixtures of components, consisting of carrier particles partially covered by fine dry particles of the drug, in this case Rabeprazole sodium. In the interests of increasing retention of the drug at the site of absorption in the oral cavity, a bioadhesive component was also added to the carrier particles. With this approach, it is possible to obtain rapid dissolution in combination with bioadhesive retention of the drug in the oral cavity. Rabeprazole sodium is an anti ulcer drug having oral bioavailability 52% due to hepatic first pass metabolism. This work aims to avoid degradation of drug in acidic environment of stomach. In this study, Rabeprazole sodium sublingual tablets were prepared by direct compression method using different bioadhesive polymers such as HPMC K4M and chitosan and sodium starch glycolate as a superdisintegrant. The effect of different concentration of polymers and superdisintegrating agents was measured by applying Box-Behnken design.
In the present study, formulation of Fast dissolving film containing antihistaminic drug Deslorat... more In the present study, formulation of Fast dissolving film containing antihistaminic drug Desloratadine was designed to achieve immediate release of drug from the dosage form, to increase therapeutic efficacy and to improve patient compliance in case of allergy. The combination of drug with suitable polymers such as HPMC E-5 and HPMC E-15 helps in providing quick onset of action. The basic aim of this work is to produce immediate release action of drug from the film. Fast dissolving film was prepared by solvent casting method using PEG 400 as plasticizer. A full factorial design was used to study the effect of HPMC E-5 and HPMC E-15 on disintegration time, thickness and folding endurance of the film. The responses were analyzed using ANOVA and by the polynomial equation. All the formulations were then evaluated for disintegration time, weight variation, and drug content and dissolution studies. Stability study shows that there was no significant change in physical appearance, disintegration time, thickness, drug content and In vitro drug release of the formulation. Fast dissolving film is an innovative concept for quick release of the drug.
Novel drug delivery systems constitute the main stay of pharmaceutical research and development. ... more Novel drug delivery systems constitute the main stay of pharmaceutical research and development. Various novel drug delivery systems exists in the pharmaceuticals and one of such delivery system is nanoparticles. Nanoparticles are monolithic systems in which the drug is adsorbed, dissolved, or dispersed throughout the matrix. There are various forms of nanoparticles, out of which a newer and novel system is buckyballs. Buckyball is a member of a class of carbon structures called fullerenes. Hence they are also known as Buckminsterfullerene or fullerene. They are discovered by British scientist Harry Kroto in 1985 and the arrangement of the atoms resembled the shape of the geodesic domes invented by architect Buckminster Fuller and hence the nanostructure is named as Buckyballs. Buckyballs are made of 60 carbon atoms formed in the shape of a hollow ball and are similar in structure to graphite, which is composed of a sheet of linked hexagonal rings but they contain pentagonal (or sometimes heptagonal) rings that prevent the sheet from being planar.Various experimental studies have been done, still going on to prove it to be advantageous and perfectly fit for the pharmaceutical field.
Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sne... more Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sneezing, runny nose and itching that a patient suffers with an allergic attack or an infection. It has poor solubility in water. Therefore, the solubility and drug release were enhanced using the solid dispersion technique and fast dissolving tablet were formulated. Solid dispersion prepared using Poloxamer 407, PEG 6000 and urea. The solid dispersion were evaluated for saturation solubility, drug content and in vitro dissolution study and it was characterized using FT-IR, X-RD, SEM and DSC study. The fast dissolving tablets of loratadine was formulated using crospovidone and crosscarmelose sodium by direct compression method. The tablets were evaluated for thickness, hardness, weight variation, friability, disintegration time and % in vitro drug release. A 32 factorial design was used to study the effect of Loratadine: Poloxamer 407 and crospovidone on disintegration time and % in vitro drug release. The responses were analyzed using ANOVA. The obtained model was validated & optimized formulation was prepared as suggested by the software.
Nanoparticles hold tremendous potential as an effective drug delivery system. In this overview we... more Nanoparticles hold tremendous potential as an effective drug delivery system. In this overview we discussed recent developments in nanotechnology for drug delivery. To overcome the problems of gene and drug delivery, nanotechnology has gained interest in recent years. Nanosystems with different compositions and biological properties have been extensively investigated for drug and gene delivery applications. To achieve efficient drug delivery it is important to understand the interactions of nanomaterials with the biological environment, targeting cell-surface receptors, drug release, multiple drug administration, stability of therapeutic agents and molecular mechanisms of cell signaling involved in pathobiology of the disease under consideration. Several anti-cancer drugs including paclitaxel, doxorubicin, 5-fluorouracil and dexamethasone have been successfully formulated using nanomaterials. Quantom dots, chitosan, Polylactic/glycolic acid (PLGA) and PLGA based nanoparticles have also been used for in vitro RNAi delivery. The use of nanomaterials including peptide-based nanotubes is a new approach to control disease progression.
Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sne... more Loratadine is a non sedative anti-histaminic drug. Its major use is in control of congestion, sneezing, runny nose and itching that a patient suffers with an allergic attack or an infection. It has poor solubility in water. Therefore, the solubility and drug release were enhanced using the solid dispersion technique and fast dissolving tablet were formulated. Solid dispersion prepared using Poloxamer 407, PEG 6000 and urea. The solid dispersion were evaluated for saturation solubility, drug content and in vitro dissolution study and it was characterized using FT-IR, X-RD, SEM and DSC study. The fast dissolving tablets of loratadine was formulated using crospovidone and crosscarmelose sodium by direct compression method. The tablets were evaluated for thickness, hardness, weight variation, friability, disintegration time and % in vitro drug release. A 32 factorial design was used to study the effect of Loratadine: Poloxamer 407 and crospovidone on disintegration time and % in vitro drug release. The responses were analyzed using ANOVA. The obtained model was validated & optimized formulation was prepared as suggested by the software.
Nanoparticles are solid colloidal particles ranging in size from 10-1000 nm. They can be used as ... more Nanoparticles are solid colloidal particles ranging in size from 10-1000 nm. They can be used as drug carrier with the drug encapsulated, dissolved, adsorbed or covalently attached. Nanoparticles are able to interact and remain associated to the ocular mucosa for extended periods of time, thus being promising carriers for enhancing and controlling the release of drugs to the ocular surface. Current studies are aimed at investigating in further detail how the interaction and internalization of these particles occurs and their toxicity following repeated administration. With breakthroughs in biotechnology, newer and more potent peptide and protein drugs are emerging in the market. The majority of these polypeptides require special delivery systems. However, since most of these compounds are very potent, require low doses, and are well absorbed from the mucous membrane; their delivery via the ocular route may be viable. However, one of the principal problems in the ocular delivery of peptide and protein drugs is that of relatively low bioavailability to the ocular tissues. This problem may be circumvented by the use of penetration enhancers.
Quality, safety and effectiveness must be built into the product. This requires careful attention... more Quality, safety and effectiveness must be built into the product. This requires careful attention to a number of factors such as the selection of quality materials/components, product and process design, control of processes, in-process control, and end-product testing. Due to the complexity of the drug products, routine end-product testing alone is not sufficient due to several reasons. Furthermore, quality cannot be tested into the finished drug product but rather be built in the manufacturing processes and these processes should be controlled in order that the finished product meets all quality specifications. A careful design and validation of systems and process controls can establish a high degree of confidence that all lots or batches produced will meet their intended specifications.The Validation Master Plan should be a summary document and should therefore be brief, concise and clear. It should not repeat information documented elsewhere but should refer to existing documents such as policy documents, SOP's and validation protocols and reports. The validation master plan should provide an overview of entire validation operation, its organizational structure & its content.
In the present study, formulation of multi-compartment dosage form containing soft gelatin capsul... more In the present study, formulation of multi-compartment dosage form containing soft gelatin capsule of Nifedipine, granules of Losartan potassium and fast disintegrating tablet of Hydrochlorothiazide was designed to achieve immediate release of drug from the dosage form, to increase therapeutic efficacy and to improve patient compliance in case of hypertension. Triple combination of antihypertensive drugs induces superior reduction in blood pressure as compared to conventional dosage form. The basic aim of this work is to produce immediate release action of drug from the hard gelatin capsule containing soft gelatin capsule of Nifedipine, granules of Losartan potassium and fast disintegrating tablet of Hydrochlorothiazide. Soft gelatin capsule was prepared by encapsulation method using propylene glycol and PEG 400 as solubilizing agents. The granules were prepared by wet granulation method using PVP K30 as binder. The fast disintegrating tablets were prepared by direct compression method using croscarmellose sodium and crospovidone as super disintegrating agents. Multi-compartment dosage form was considered as optimized formulation for immediate release of antihypertensive drugs.
Capsule dosage form is most convenient and relevant dosage form. Soft gels are becoming a popular... more Capsule dosage form is most convenient and relevant dosage form. Soft gels are becoming a popular dosage form for the administration of liquids, suspensions, pastes and dry powders. Soft gels are easy to swallow and have the ability to mask odors and unpleasant taste. They have an elegant appearance, readily dissolve in the gastric juices of the digestive tract and they may enhance the bioavailability of the active ingredients. Nifedipine, a calcium-channel blocking agent, is widely used in the treatment of angina pectoris and systemic hypertension. Half life of the drug is comparatively short 2 hours and Nifedipine is completely insoluble in water. Therefore, it has been generally accepted that soft gelatin capsule (Softgels) formulations are most efficient for routine hypertension therapy with Nifedipine. The main objective of the study was to formulate and evaluate soft gelatin capsule dosage form of Nifedipine used in the treatment of hypertension using oily polymers like propylene glycol and PEG 400 to enhance the solubility of Nifedipine.
Bilayer tablet is new era for successful development of controlled release formulation along with... more Bilayer tablet is new era for successful development of controlled release formulation along with various features to provide successful drug delivery system. Bilayer tablets can be a primary option to avoid chemical incompatibilities between API by physical separation and to enable the development of different drug release profiles. The manufacture of bilayer tablets produced by sequential compaction of loose powder layers has become of increased interest within the pharmaceutical industry due to the tailored release profiles of active ingredients that may be obtained. Bilayer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet. The immediate release layer of bilayer tablet has worked as the loading dose and the sustained release layer has maintained therapeutic plasma drug concentration for prolonged time. Using a modified tablet press may therefore be the best approach in producing a quality bilayer tablet under GMP conditions, especially when high production output is required.
Oral drug delivery systems being the most cost-effective and leads the worldwide drug delivery ma... more Oral drug delivery systems being the most cost-effective and leads the worldwide drug delivery market. The major problem in oral drug system is low and erratic bioavailability, which mainly results from poor aqueous solubility. This may lead to high inter and intra subject variability, lack of dose proportionality and therapeutic failure. For the improvement of bio-availability of drugs with such properties presents one of the greatest challenges in drug formulations. Various technological strategies are reported in the literature including solid dispersions, cyclodextrines complex formation and micronization. Including these approaches self-emulsifying drug delivery system (SEDDS) has gained more attention for enhancement of oral bio-availability with reduction in dose. SEDDS are isotropic mixtures of oil, surfactants, solvents and co-solvents/surfactants. For lipophilic drugs, which have dissolution rate-limited absorption, SEDDS may be a promising strategy to improve the rate and extent of oral absorption. This book explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.
Recent advances in novel drug delivery system aims to enhance safety and efficacy of drug molecul... more Recent advances in novel drug delivery system aims to enhance safety and efficacy of drug molecule by formulating a convenient dosage form for administration and to achieve better patient compliance. One such approach is fast dissolving tablets (FDT) of Phenylephrine Hydrochloride, a selective α1 adrenergic receptor antagonist, used for nasal decongestant and producing mydriasis effect. In present work an attempt has been made by formulating fast dissolving tablets of Phenylephrine Hydrochloride by superdisintegrants addition method using croscarmellose sodium, crospovidone and sodium starch glycolate. A total of 10 batches were prepared by using various combination and concentration of superdisintegrants and evaluated for general appearance and physical parameters, drug content, in vitro disintegration, in vitro dispersion, in vitro drug release studies, kinetic studies and stability studies. Amongst all the formulations F2 and F9 were found to be better formulations which include single superdisintegrants and combination of superdisintegrants. Finally it was concluded that FDT of Phenylephrine Hydrochloride will be used as a novel drug dosage form for pediatrics and geriatrics.
In ayurveda, most of the drugs were given in the form of powder, kasaya (decoction form) or bhasm... more In ayurveda, most of the drugs were given in the form of powder, kasaya (decoction form) or bhasma. In present study, topical formulations were prepared for local effect. The main objective of present study was to develop semisolid dosage form of Panchatikta extract using emulsifying ointment BP and Carbopol-941 as a base. The work was focused on reducing the total dosage size and incorporating more amounts of active principles in the dosage form. All formulations were evaluated for pH, spreadibility, viscosity and antimicrobial activity. Emulsifying ointment BP base was found to the best as compared to that of gel base. The antimicrobial activity was carried out using E. coli and S. aureus. The results showed that zone of inhibition of formulation FIe prepared by emulsifying ointment base was found to be 18.3 for S. aureus and 17.4 for E. coli, pH was 6.4 and spreadibility was 4.06 cm. The stability data indicated that the formulation was a stable preparation.
The naturally occurring polyphenol resveratrol (RES) has attracted increasing attention in recent... more The naturally occurring polyphenol resveratrol (RES) has attracted increasing attention in recent years due to its antioxidant, anti-inflammatory, and anticancer activity. However, resveratrol's promising potential as a nutraceutical is hindered by its poor aqueous solubility, which limits its biological activity. Here we show that encapsulating resveratrol in colloidal mesoporous silica nanoparticles (MCM-48-RES) enhances its saturated solubility by ∼95% and increases its in vitro release kinetics compared to pure resveratrol. MCM-48-RES showed high loading capacity (20% w/w) and excellent encapsulation efficiency (100%). When tested against HT-29 and LS147T colon cancer cell lines, MCM-48-RES-mediated in vitro cell death was higher than that of pure resveratrol, mediated via the PARP and cIAP1 pathways. Finally, MCM-48-RES treatment also inhibited lipopolysaccharide-induced NF-κB activation in RAW264.7 cells, demonstrating improved anti-inflammatory activity. More broadly, our observations demonstrate the potential of colloidal mesoporous silica nanoparticles as next generation delivery carriers for hydrophobic nutraceuticals.
Fast dissolving tablets (FDT) of Phenylephrine Hydrochloride, a selective α1 adrenergic receptor ... more Fast dissolving tablets (FDT) of Phenylephrine Hydrochloride, a selective α1 adrenergic receptor antagonist, used for nasal decongestant and producing mydriasis effect. In present work an attempt has been made by formulating fast dissolving tablets of Phenylephrine Hydrochloride by superdisintegrants addition method using croscarmellose sodium, crospovidone and sodium starch glycolate. A total of 10 batches were prepared by using various combination and concentration of superdisintegrants and evaluated for general appearance and physical parameters, drug content, in vitro disintegration, in vitro dispersion, in vitro drug release studies, kinetic studies and stability studies. Amongst all the formulations F2 and F9 were found to be better formulations which include single superdisintegrants and combination of superdisintegrants. F2 formulation containing crospovidone (5% w/w) showed rapid in vitro disintegration time (12.3333 ± 1.7453 seconds), rapid in vitro dispersion time (14.666...
Novel drug delivery systems constitute the main stay of pharmaceutical research and development. ... more Novel drug delivery systems constitute the main stay of pharmaceutical research and development. Various novel drug delivery systems exists in the pharmaceuticals and one of such delivery system is nanoparticles. Nanoparticles are monolithic systems in which the drug is adsorbed, dissolved, or dispersed throughout the matrix. There are various forms of nanoparticles, out of which a newer and novel system is buckyballs. Buckyball is a member of a class of carbon structures called fullerenes. Hence they are also known as Buckminsterfullerene or fullerene. They are discovered by British scientist Harry Kroto in 1985 and the arrangement of the atoms resembled the shape of the geodesic domes invented by architect Buckminster Fuller and hence the nanostructure is named as Buckyballs. Buckyballs are made of 60 carbon atoms formed in the shape of a hollow ball and are similar in structure to graphite, which is composed of a sheet of linked hexagonal rings but they contain pentagonal (or som...
Quality, safety and effectiveness must be built into the product. This requires careful attention... more Quality, safety and effectiveness must be built into the product. This requires careful attention to a number of factors such as the selection of quality materials/components, product and process design, control of processes, in-process control, and end-product testing. Due to the complexity of the drug products, routine end-product testing alone is not sufficient due to several reasons. Furthermore, quality cannot be tested into the finished drug product but rather be built in the manufacturing processes and these processes should be controlled in order that the finished product meets all quality specifications. A careful design and validation of systems and process controls can establish a high degree of confidence that all lots or batches produced will meet their intended specifications.The Validation Master Plan should be a summary document and should therefore be brief, concise and clear. It should not repeat information documented elsewhere but should refer to existing documen...
Nanoparticles hold tremendous potential as an effective drug delivery system. In this overview we... more Nanoparticles hold tremendous potential as an effective drug delivery system. In this overview we discussed recent developments in nanotechnology for drug delivery. To overcome the problems of gene and drug delivery, nanotechnology has gained interest in recent years. Nanosystems with different compositions and biological properties have been extensively investigated for drug and gene delivery applications. To achieve efficient drug delivery it is important to understand the interactions of nanomaterials with the biological environment, targeting cell-surface receptors, drug release, multiple drug administration, stability of therapeutic agents and molecular mechanisms of cell signaling involved in pathobiology of the disease under consideration. Several anti-cancer drugs including paclitaxel, doxorubicin, 5-fluorouracil and dexamethasone have been successfully formulated using nanomaterials. Quantom dots, chitosan, Polylactic/glycolic acid (PLGA) and PLGA based nanoparticles have a...
Nanoparticles are solid colloidal particles ranging in size from 10-1000 nm. They can be used as ... more Nanoparticles are solid colloidal particles ranging in size from 10-1000 nm. They can be used as drug carrier with the drug encapsulated, dissolved, adsorbed or covalently attached. Nanoparticles are able to interact and remain associated to the ocular mucosa for extended periods of time, thus being promising carriers for enhancing and controlling the release of drugs to the ocular surface. Current studies are aimed at investigating in further detail how the interaction and internalization of these particles occurs andtheir toxicity following repeated administration. With breakthroughs in biotechnology, newer and more potent peptide and protein drugs are emerging in the market. The majority of these polypeptides require special delivery systems. However, since most of these compounds are very potent, require low doses, and are well absorbed from the mucous membrane; their delivery via the ocular route may be viable. However, one of the principal problems in the ocular delivery of pe...
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