Litrature Review:: KCT'S R.G. Sapkal. College of Pharmacy, Anjaneri, Nashik

CHAPTER-4 LITERATURE REVIEW
4. LITRATURE REVIEW:
Verma. R et.al.[37][2002] Glipizide's extended release formulation based on osmotic

technology has been developed and assessed. The effects of various formulation variables
were analysed, namely the level of core solubility modifier, membrane weight gain, and
the level of membrane pore former. Drug release was found to be influenced in the core
formulation by the degree of solubility modifier. The release of glipizide was inversely
proportional to the weight of the membrane but directly related to the membrane's initial
level of pore former (PVP). With an increase in the amount of the former pore in the
membrane, the burst force decreased. SEM study results showed the formation of pores
in the membrane from which the release of the drug occurred. The manufacturing process
was found to be reproducible and, after 3 months of rapid stability tests, the formulations
were stable.
Rani. M et.al.[38][2003] Established osmotic pump tablet of Diclofenac sodium. This

study indicates that Diclofenac Sodium osmotic pump tablets, as potential extended and
managed release dosage types, may perform therapeutically much better than traditional
commercial Diclofenac Sodium tablets, which could lead to improved efficacy and better
patient compliance.
Kumar. P et.al. [39][2004] The development of the elementary osmotic pump

tablet(OPT) of Naproxen sodium for per-oral administration was studied primarily with
the objective of delivering a constant, pre-determined quantity of medication over an
extended period in solution form. Core OPT tablets, various osmogens, microcrystalline
cellulose (MCC), PVP and optional excipients such as sodium lauryl sulphate (SLS) and
sodium bicarbonate (SBC) on the tablet machine were prepared by compression using
drugs. Using 2 % w / v cellulose acetate dissolved in IPA: acetone (1:9) blend, core
tablets were coated. All the OPT were tested for physical parameters and in vitro drug
release characteristics in sequenced GI fluid. The drug release findings from OPT showed
controlled and prolonged release of NS relative to the typical marketed NS formulation.
KCT’S R.G. SAPKAL. COLLEGE OF PHARMACY, ANJANERI, NASHIK.

Page 30
Longxiao. L et.al.[40][2008] A technique for the preparation of the monolithic osmotic

pump tablet was formed by coating the indented core tablet with a needle compressed by
the punch. Atenolol, sodium chloride as an osmotic agent and polyethylene oxide as a
suspending agent, were used as the model drug. As a semi-permeable membrane
containing polyethylene glycol 400, ethyl cellulose has been used as a plasticizer to
control membrane permeability. The ideal osmotic tablet was found to be capable of
delivering Atenolol up to 24 h at an approximately constant rate, independent of the
release media as well as the rate of agitation.
Hussan Kh et.al. [41][2011] The monolithic osmotic tablet system, which is composed
of a monolithic tablet coated with cellulose acetate ( CA) and membrane drilled with two
orifices on both side surfaces, has been identified. The effects of tablet formulation
variables, including the volume of sodium chloride (NaCl) polymer Explotab (Expt),
have been studied. The optimal tablet formulation and co-controlled delivery mechanisms
of theosmotic-suspending have been suggested. Orifice size and membrane variables
were also analysed, including the type and quantity of plasticizers as well as drug release
thickness. The in vitro release profiles of the optimal method were tested and contrasted
with commercialised traditional tablets in different release media and different rates of
agitation. It was found that Explotab was suitable to be thickening agent, both amount of
NaCl and amount of Explotab had comparable and profoundly positive effects. The
optimum orifice size was found to be 800 μm. It has also been observed that hydrophilic
plasticizer polyethylene glycol ( PEG) enhanced drug release, when they were integrated
in CA membrane. The monolithic osmotic tablet device was found to be able to deliver
Aceclofenac at the rate of approximate zero-order up to 24 h, independent of both
environmental media and agitation rate, and significantly comparable with the
commercialised traditional tablet.
Shahi R. Sadhana et.al.[42][2012] The current work aims to design and improve
extended release formulations based on osmotic technology using a managed porosity
approach to the free water-soluble drug diltiazem hydrochloride (DLTZ). As it is openly
water-soluble and has a short half-life (2-3 h), DLTZ is an ideal candidate for a zero-
order drug delivery system. To change the solubility of DLTZ in an aqueous medium,
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sodium chloride (Osmogen) was applied to the core tablet. Cellulose acetate (CA) and
sorbitol were used as semipermeable membrane and pore former, respectively. The effect
was studied on the in vitro release of different formulation variables, namely osmogen
concentration in the core tablet, percent pore former, percent weight gain, pH of the
dissolution medium, and agitation rate. DLTZ release was directly proportional to the
previous percent pore and inversely proportional to the weight gain percentage. The
optimised formulation (F8) delivered DLTZ at the upper level of percent pore
concentration former (25 percent w / w) and middle level concentration of percent weight
gain (6 percent w / w) independent of pH and agitation rate for 12 h. The Elementary
Osmotic Pump (EOP) and Regulated Porosity Osmotic Pump comparative study showed
that it is superior to traditional EOP and also simpler and more cost-effective to
formulate.
Fouladi Fernaz et.al.[43][2012] Floating tablets of bupropion HCl were successfully

developed in this study. HPMC is a matrix material for designing floating tablets and
appropriate blending with NaCMC can yield floating tablets with suitable drug release
and swelling characteristics. However, further studies, including in vivo investigations,
are necessary to confirm the findings of this work.
Nihar. S et.al.[44][2013] The purpose of the investigation was to design and develop the
controlled release formulation of Captopril based on osmotic pump controlled porosity
technology in order to increase residence time in order to enhance the therapeutic effect
of the drug by improving its bioavailability. The drug investigation involves Captopril,
SLS, Trimethamine, mannitol, lactose, povidone K30. FTIR and DSC studies checked
drug compatibility with excipients. All the formulations showed that drug release was
dominated by diffusion.
Edavalath. S et.al. [45][2014] A procedure for the preparation of Aceclofenac 's

managed oral drug delivery system. Over a long period of time, medicines can be
distributed by osmotic technology in a controlled fashion. There is a drug centre in the
formulation and it is covered with a semi-permeable membrane. The formulation design
was carried out using design expert software by multi-level category factorial design. To

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improve the solubility of the drug, the solid dispersed form of Aceclofenac has been used.
Osmotic agent concentration (potassium chloride), solubility enhancer (sodium lauryl
sulphate), and percentage of weight gain after coating were considered as dependent
variables. Cellulose acetate (80 percent) and PEG 4000 (20 percent) coated the core
tablets. For the physicochemical parameters and drug release studies, all the formulations
were studied. The optimised formulations demonstrate stable, independent physiological
properties of controlled drug delivery of Aceclofenac over a 24-hour period.
Andhale. S et.al.[46][2014] An elementary Quetiapine fumarate osmotic pump has been

developed. Sodium chloride was used as an osmotic agent that provides the driving force
inside the core tablet that leads to drug release. Microcrystalline cellulose was used as a
release retardant and Cellulose acetate as a plasticizer as a semi-permeable membrane
containing polyethylene glycol 400. The prepared tablet was found to deliver Quetiapine
fumarate at a constant rate of up to 24 hours, thereby reducing dos dos
Aalla.V.Krishna et.al.[47][2015] An attempt was to create oral sustained release tablets

of the Bupropion hydrochloride matrix using the direct compression method of HPMC
K100, Carbopol, and Eudragit. For pre-compression assessments (angle of repose, bulk
density, tapped density, Carr's index, Hausner 's ratio), the in-vitro characteristics of the
blends of different formulations were assessed. This shows satisfactory results. The
tablets have been subjected to studies of friability, weight variation, thickness, drug
hardness content, and in vitro release. Using USP dissolution apparatus II(paddle) in
900ml 0.01 HCl solution as dissolution media, the in- vitro dissolution analysis was
performed for 12 hours. The quantity of drugs released was calculated by a UV-visible
spectrophotometer at 280 nm. From the findings, F6 was found to be 12 hours of 99.21
percent release and finalised as an optimised formula.
Udawant. S et.al. [48][2015] Candesartan Cilexetil 's elementary osmotic pump tablet
was formulated using sodium chloride as a main ingredient that gives osmogenic property
that provides driving force within the core tablet and leads to drug release.
Microcrystalline cellulose in the present study was used as a release retardant content. By
varying the concentrations using 32 factorial designs, various formulations were prepared.

Page 33
It was applied to see the effects of variables sodium chloride and MCC on the response
percentage drug release as a dependent variable. Using 5 % w / v cellulose acetate (CA)
in acetone and PEG 400 (15%) used as plasticizer, the tablets were coated with a semi-
permeable membrane. The rate of drug release was directly proportional to the size of the
delivery orifice. The SEM analysis was conducted to detect the scale of the delivery
orifice diameter. For 3 months of accelerated stability testing, the optimised formulation
was stable.
Kokane. P et.al.[49][2016] Benazepril Hydrochloride 's elementary osmotic pump tablet

was formulated using sodium chloride as a main ingredient that provides osmogenic
property that gives driving force within the core tablet and leads to drug release.
Microcrystalline cellulose in the present study was used as a release retardant content. By
varying the concentrations using 32 factorial designs, various formulations were
prepared. It was used to see the effects of sodium chloride and MCC variables on the
drug release percentage response as a dependent variable. Using 5 % w / v cellulose
acetate (CA) in acetone and PEG 400 (15%) used as plasticizer, the tablets were coated
with a semi-permeable membrane. The rate of drug release was directly proportional to
the size of the delivery orifice. The SEM analysis was conducted to detect the scale of the
delivery orifice diameter. For 3 months of accelerated stability testing, the optimised
formulation was stable.
Wagh. Y et.al. [50][2016] Cyproheptadine hydrochloride's push-pull osmotic tablet was

formulated using sodium chloride as a key ingredient that gives osmogent property,
which provides driving force within the core tablet from the push layer (lower layer) and
leads to drug release from the drug layer. In the present work, hydroxy propyl methyl
cellulose was used as a release retardant material. Different formulations were prepared
using 32 factorial design by varying the concentrations. A dependent variable was used to
see it.
Khandangle P.et.al.[51][2017] The results of experimental studies of Lisinopril
Dihydrate Osmotic Tablets showed that the Lisinopril Dihydrate Granules showed strong
flow properties, tablet evaluation tests were within the appropriate limits, IR spectral
analysis showed that there was no interaction between drug-excipients, kinetic studies
Page 34
showed that all the formulations followed zero order drug release kinetics and stabi The
results of the above study clearly indicated that the Lisinopril Dihydrate Produced
Osmotically Controlled Release Tablet provides drug release at a predetermined rate and
in a controlled manner for a predetermined period.
Shivnikar M. et.al.[52][2020] By monitoring of the chosen formulation variables, the
desired release of Verapamil HCl from the CPOP was achieved. In addition, the release
from the CPOP studies showed that while preserving the required release properties of
the formulation, the desired quality of the method could be considered. The effect of
different pore former in three different concentrations tested in the analysis , which shows
that sorbitol gives good and desired release according to USP acceptance criteria in the
25 percent w / w concentration. It was obvious that it was found that the rise in pore
concentration formerly increased the release of the drug from the system.

Page 35

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CHAPTER-4 LITERATURE REVIEW

Verma. R et.al.[37][2002] Glipizide's extended release formulation based on osmotic

Rani. M et.al.[38][2003] Established osmotic pump tablet of Diclofenac sodium. This

Kumar. P et.al. [39][2004] The development of the elementary osmotic pump

KCT’S R.G. SAPKAL. COLLEGE OF PHARMACY, ANJANERI, NASHIK.

Longxiao. L et.al.[40][2008] A technique for the preparation of the monolithic osmotic

Fouladi Fernaz et.al.[43][2012] Floating tablets of bupropion HCl were successfully

Edavalath. S et.al. [45][2014] A procedure for the preparation of Aceclofenac 's

KCT’S R.G. SAPKAL. COLLEGE OF PHARMACY, ANJANERI, NASHIK.

Andhale. S et.al.[46][2014] An elementary Quetiapine fumarate osmotic pump has been

Aalla.V.Krishna et.al.[47][2015] An attempt was to create oral sustained release tablets

KCT’S R.G. SAPKAL. COLLEGE OF PHARMACY, ANJANERI, NASHIK.

Kokane. P et.al.[49][2016] Benazepril Hydrochloride 's elementary osmotic pump tablet

Wagh. Y et.al. [50][2016] Cyproheptadine hydrochloride's push-pull osmotic tablet was

KCT’S R.G. SAPKAL. COLLEGE OF PHARMACY, ANJANERI, NASHIK.

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