PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 

 
Components  that  must  be  added  to  the  therapeutic  Ingredient 
TABLETS & TABLET COATING are classified according to their functions and are grouped into: 
TABLETS  ● Essential components 
➜ Are  solid  dosage  forms  containing  medicinal  substances  with  or  ○ Diluent or Bulking Agent 
without suitable diluents  ○ Binders or Granulators 
  ○ Disintegrants 
Advantages of Tablets Over Some Oral Medication  ● Compression Aids  
✓ Precision of dosage  ○ Glidants 
✓ Durability  of  physical  characteristics  for  extended  period  of  ○ Lubricants 
storage  ○ Anti-adhesives 
✓ Stability of chemical and physiologic activity of drugs  ● Supplementary Components 
✓ Convenience of administration  ○ Colors 
  ○ Flavors 
Quality Attributes of Tablets  ○ Sweetening Agents 
✓ Tablets should include the correct dose of the drug  ○ Adsorbents 
✓ The  appearance  of  the  tablet  should  be  elegant  and  its  weight,  - These are also used for identification purposes. 
size and appearance should be consistent   
✓ Drugs  should  be  released  from  the  tablet  in  a  controlled  and  ESSENTIAL COMPONENTS 
reproducible way   
✓ Tablet  should  be  biocompatible,  i.e.,  not  include  excipients,  Diluents 
contaminants  and  microorganisms  that  could  cause  harm  to  ● Also known as Bulking agents 
patients  ● Substances  that  make  up  the  large  portion  or  major  portion  of 
✓ Tablet  should  be  of  mechanical  strength  to  withstand  fracture  the tablets 
and erosion during handling  ○ Lactose 
✓ Tablet  should  be  chemically,  physically  and  microbiologically  ○ Starches 
stable during the lifetime of the product  ○ Mannitol 
✓ Tablet  should  be  formulated  into  a  product  acceptable  by  the  ○ Sorbitol 
patient  ○ Sucrose 
✓ Tablet should be packed in a safe manner   ○ Microcrystalline cellulose 
   
CLASSIFICATION OF TABLETS  Binders 
  ● Binding agent or adhesive   
ACCORDING TO METHOD OF MANUFACTURE  ● Substances  that  glue  powders  together  and  cause  them  to form 
● Compressed tablets  granules 
○ usually prepared by large scale production methods  ● Impart cohesive qualities to the powdered material 
● Molded tablets  ● Dependent  on  the  choice  of  proper  binding  agent,  quantity used 
○ Involve small scale operations  and form of binder when added 
  ○ Starch paste (10-20%) 
Compressed Tablets  ○ Aqueous gelatin solution (10-20%) 
✓ Sugar coated tablets  ○ Aqueous glucose solution (25-50%) 
✓ Film coated tablets  ○ Alcoholic solution of ethylcellulose (5%) 
✓ Enteric coated tablets   
✓ Multiple  compressed  tablets  -  layered  tablets,  press-coated   
tablets  Disintegrant 
✓ Prolonged action tablets  ● Material  that  help  the  tablet  break  up and dissolve to release the 
✓ Tablets for solution  medicament for rapid dissolution 
✓ Effervescent tablets  ○ Starches (Corn & potato) 
✓ Tableted suppositories or inserts  ○ Clays 
✓ Buccal and sublingual tablets  ○ Cellulose 
  ○ Algins 
Molded Tablets/Tablet Triturates  ○ Gums 
✓ Dispensing tablets  ○ Effervescent mixtures 
✓ Hypodermic tablets   
  COMPRESSION AIDS 
Compressed tablets   
➜ Ability to withstand the rigors of mechanical treatment involved in  Glidants 
production, packaging, shipment and dispensing  ● Materials  added  to the formulation to enable the granules to flow 
➜ Freedom from defects  from  a  hopper  on  the  tablet  press  to  the  die  and  for  consistent 
➜ Reasonable  chemical  and  physical  stability  during  average  and uniform fill 
storage condition  ○ Talcum 
➜ Ability  to  release the medicament in reproducible and predictable  ○ Corn starch 
manner   
     

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Lubricants  TABLET PRESSES 
● Materials  which  will  aid  in  releasing  the  compressed  tablet  from  ● Tablets  are  formed  by  the  compression  of  various  materials  on 
the die  stamping machines called p ​ resses 
○ Metallic  ● Basic elements of a tablet press​ consist of  
○ Stearic acid (Calcium stearate, Sodium stearate)  ○ Hopper 
○ High melting point waxes  ○ Feed frame 
○ Corn starch  ○ Dies 
  ○ Punches 
Antiadhesives  ○ Cams 
● Materials  needed  to  prevent  the  formulation  of  residue  films  of  ● All  other  parts  of  a  tablet  press  are  designed  to  control  the 
tablet granulation on the punches  functioning of those listed above. 
○ Talcum  ● Features  such  as  capacity​,  ​speed​,  ​maximum  weight  and 
○ Metallic  (in  the  form  of  Calcium  stearate,  Magnesium  pressure  vary  with  the  design  of  the  equipment,  but  the  basic 
stearate)  elements remain essentially the same.  
○ Corn starch  ● We place the granules inside a ​hopper​, then it will pull down using 
  the  ​feed  frame.  ​Then  after  that,  papasok  siya  sa  tablet  dies  ⟶ 
SUPPLEMENTARY COMPONENTS  punch ⟶ cam.  
  ● The cam will guide the punches.  
Colorants  ● We have the upper punch and the lower punch.  
● FD & C (used in food, drugs, and cosmetics)  ○ Upper punch​ would descend to c ​ ompress​ the tablet. 
● D & C (for drug and cosmetic)  ○ Lower punch w ​ ould ascend to ​eject​ the tablet. 
● Free dyes (are water-soluble)  ● Basic  mechanical  unit  tablet  compression  involves  the  operation 
● Lakes (are water-​in​soluble pigment)  of  two  steel  punches  (upper  and  lower)  within  a  steel  die  cavity. 
● Lakes  are  dyes  absorbed  in  aluminum  hydroxide.  They  are  These toolings form the tablet. 
almost  completely  insoluble  in  water,  in  which  they  may  bleed  ● The  tablet  assumes  the  size  and  shape  of  the  punches  and  dies 
slightly.   used. 
● Photosensitive in varying degrees  ● Curvature  of  the  faces  of  the  punches  determines  the  curvature 
● Main problem encountered M ​ ottling  of the tablets. 
  ● Weight  of  the  tablet  is  determined  by  the volume of the material 
Flavors and Sweeteners  which fills the die cavity. 
● Frequently used in chewable tablets  ● Thickness  can  vary  due  to  the  density  of  the  granulation, 
● Flavors  are  available  as  oils  and  as  spray  dried  beadlets.  They  pressure applied to the tablet or the speed of tablet compression. 
are  never  incorporated  during  wet  processing,  since  subsequent   
drying  would  reduce  the  concentration  of  these  volatile  2 TYPES OF TABLET COMPRESSION 
ingredients.  ● Single punch 
● Aqueous  flavors  are  not  recommended  since  water  would  ● Multistation rotary presses 
interfere with tableting causing ​sticking   
● Sometimes we add a diluent that are already sweet like:  Care of Compression Machines 
○ Lactose  ✓ Proper  maintenance  of  the  punches  and  dies  cannot  be 
○ Sucrose  overemphasized for a number of valid reasons. 
○ Mannitol  ✓ Do  not  allow  the  punches  to  drop  on  concrete  or  similar  hard 
○ Dextrose  surfaces which will chip the fine edge. 
○ Saccharin  (500x  as  sweet  as  sucrose  but  with  bitter  after  ✓ Never  allow  the  upper  and  lower punch faces to come in contact 
taste)  with each other 
  ✓ After  the  completion  of  a  compression  run,  the  toolings  are 
Adsorbents  removed  from  the  machine,  washed  thoroughly  in  warm  soapy 
● Substances  capable  of  holding  large  quantities  of  fluids  in  an  water, then dried with clean towel or cloth 
apparently dry state  ✓ Storage  in  hard  paper  tubes  in  which  punches  are  shipped  from 
● Useful  when  ethereal  oils,  ethereal  solutions  of  oil-soluble  drugs,  the  factory,  or  hanging  them  in  wooden  racks  after  thorough 
fluid extracts and eutectic melts are part of the tablet formulation  lubrication is recommended 
● Silicon  dioxide  possesses  a  vast  surface  area,  it  can  hold  up  to   
50% of its weight in water and still as a free flowing powder  Tablet  Machines  should  receive  the  best  possible  care  to  insure 
○ Magnesium carbonate  maximum operating efficiency, observe the following rules:  
○ Magnesium hydroxide  ✓ Keep the machines clean 
○ Bentonite  ✓ Keep parts properly lubricated 
○ Kaolin  ✓ Avoid overloading 
○ Magnesium aluminum silicate  ✓ Insert dies carefully 
○ Tricalcium phosphate   
○ Dried starch   TABLET GRANULATION 
  ● Granulation  -  pharmaceutical  process  that  attempts  to  convert 
  powdered materials into aggregates called ​granules  
  ● Granules should possess ー ​Fluidity and Compressibility 
   
     

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Good Tablet Granulation should:   WET GRANULATION 
● Contain particles which approach s​ pherical​ shape  ➜ Most  widely  used  and  most  general  method  for  preparing  a 
● Present  a  range  of  particle  sizes  that  resembles  a  normal  tablet  granulation  that  will  satisfy  the  physical  requirements  for 
distribution  curve,  with  a  small  percentage  of  of  coarse  and  fine  the compression of good tablets 
particles and with the rest in a narrow range between   
● Have  a  uniform  distribution  of  all  the  ingredients  in  the  Disadvantages of Wet Method 
formulation  ✓ Involves several separate steps 
● Possess  compressible  components  that  will  confer  physician  ✓ Requires longer processing time 
strength and form to the tablet   ✓ Labor cost is high 
   
MANUFACTURING TECHNIQUES  Steps in the Wet Method 
● Dry Methods  ● Dry method: Six ​(6)​ steps 
○ Direct compression and granulation by compression  ● Wet method: Eight (​ 8)​ steps 
● Wet Methods   
○ Wet  granulation  and  special  procedures/related  1. Weighing of the ingredients 
granulation processes  2. Mixing them in a suitable mixer or blender 
  3. Granulation  into  a  damp/moist mass by the addition of a binding 
Dry Methods  solution 
➜ Preferred  than  wet  methods  by  most  manufacturers  for  4. Screening the mass by forcing through a​ 6- or 8-​ mesh screen 
economic​ reasons and s​ tability​ considerations  5. Drying in suitable ovens or fluid bed dryers 
➜ Dry  processes  do  not  require  the  equipment  and  handling  6. Dry screening through a smaller mesh screen (see next table) 
expenses required in wetting and drying procedures  7. Lubrication in a suitable blender 
➜ May  obviate  loss  of  activity  with  those  drugs  that  are  moisture-  8. Compression into final tablets 
and heat-sensitive   
  RECOMMENDED SCREEN SIZE FOR DRY SCREENING GRANULATION 
Disadvantages of Dry Method 
TABLET SIZE (diameter)  SCREEN SIZE 
✓ Limited  to  a  few  crystalline  substances,  such  as  inorganic  salts 
(NaCl,  NaBr,  KCl),  which  may  compressed  directly;  the  vast  Up to 3/16 inch  20 mesh 
majority of medicinal agents are rarely so easy to tablet  7/32 to 5/16 inch  16 mesh 
✓ Compression  of  a  single  substance  may  produce  tablets  that do  11/32 to 13/32 inch  14 mesh 
not disintegrate  7/16 inch and larger  12 mesh 
✓ When  other  components  are  needed,  these  may  interfere  with   
the  compressibility  of  the  active ingredient and thus minimize the  SPECIAL  PROCEDURES  TO  PROMOTE  FLUIDITY  AND 
usefulness of the method  COMPRESSIBILITY  OF  MATERIALS  BY  FORMING  SPHERICAL 
✓ Effective  dose  of  many  drugs  is  so small that direct compression  GRANULES OR BEADS 
would be impractical and uneconomical  ● Spheronization 
✓ To  mitigate  these  problems, the active ingredients is mixed with a  ● Spray drying 
directly  compressible  vehicle  such  as  spray  dried  lactose,  ● Spray congealing or spray chilling 
anhydrous  lactose,  calcium  phosphate,  mannitol,  sorbitol  and   
microcrystalline cellulose (14:48)  SPHERONIZATION 
  ➜ Form  of  pelletization  which  consists  of  extruding  a  wet 
GRANULATION BY COMPRESSION  granulation  containing  the  active  drug,  diluent  (if  needed)  and 
● Also  known  as  ​dry  granulation​,  precompression  or  double  binder  into  spheronization  equipment  called  ​MARUMERIZER 
compression method  MACHINE. 
● Involves  compaction  of  finely  divided  powdered  materials  into  ➜ Extruded  rod  shaped  cylindrical  segments  are  shaped  into 
large, poorly formed but firm masses called S ​ LUGS.  spheres by centrifugal and frictional forces on a rotating screen.  
○ These  are  subsequently  screened  or  milled  in  order  to  ○ The  pellets  are  then  dried  by  conventional  methods, mixed 
produce  a  granular  form  of  tabletting  material  possessing  with suitable lubricants, and compressed into tablets. 
the essential characteristics of a good granulation   
  Advantages of Spheronization 
Dry Granulation includes the following steps:   ✓ Production  of  granules  which  are  regular  in  shape,  size  and 
1. Weighing of ingredients  surface characteristics 
2. Mixing of ingredients in a suitable mixer or blender  ✓ Low friability resulting in fewer fines 
3. Slugging by using flat face punches 7/8 to 1 inch diameter  ✓ Ability to regulate the size of the spheres 
4. Dry  screening  of  slugs  through  a  mesh  screen  (by  hand)  or   
through a ​Fitzpatrick​ comminuting mill     
5. Lubrication through a suitable blender 
➢ This  second  to  the  last  stage,  lubrication  before 
compression, is also known as Bolting. 
➢ We add lubricant before compression. 
6. Compression into final tablets 
 
 
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
SPRAY-DRYING  SEVERAL FACTORS WHICH MAY CAUSE M ​ OTTLING 
➜ Consists  of  bringing  together  a  highlighly  dispersed  liquid  and  a  ● A  drug  that  differs  in  colors  from  its  excipients  or  whose 
sufficient  volume  of  hot air to produce evaporation and drying of  degradation  products  are  highly  colored.  The  former  is  masked 
the liquid droplets.  by the use of a dye. 
➜ The feed liquid may be a  ● Migration of dye during granulation can be remedied by:  
○ Solution  ○ Change of the solvents system 
○ Slurry  ○ Reduction of drying temperature 
○ Emulsion  ○ Reduction of granulation to smaller particle size 
○ Gel or paste  ● Addition  of  hot  colored  adhesive  solutions  to  a  much  cooler 
↳ provided  it  is  pumpable  and  capable  of  being  powder  mixture  will  produce  mottling  because  the  adhesive  that 
atomized  comes  out  of  solution  carries  most  of  the  color  with it. Remedies 
  to this situation are: 
SPRAY-CONGEALING OR SPRAY-CHILLING  ○ Further wetting 
➜ Similar to spray drying and uses the same basic equipment  ○ Incorporate  the  adhesives  before  adding  the  granulating 
➜ Main difference lies in the ​absence of heat​ in the process  fluid 
➜ Consists  of  melting  solids  and reducing them to beads or powder  ○ Disperse the dry color additive during the powder blending 
by  spraying  the  molten  feed  into  a  steam  of  ambient  or  cooled   
air  or  other  gas.  The  choice  of the latter depends on the freezing  USP OFFICIAL TESTS FOR TABLETS 
point of the product.  ✓ Weight Variation 
  ✓ Hardness Variation 
MOST COMMON PROCESSING PROBLEMS  ✓ Double Impression - ​for tablets lang talaga ‘yan 
✓ Tablet Disintegration 
Partial or complete separation of the top or bottom of 
Capping  ✓ Tablet Dissolution 
the tablet from the main body 
✓ Tablet Friability 
Chipping  Separation of small piece of tablet surface after ejection 
 
Lamination  Separation of a tablet into 2 or more distinct layers  TABLET COATING 
Removal of material from the surface of the tablet, and  ➜ Application  of  coating  material  to  the  exterior  of  the  tablet  with 
Picking 
its adherence to the face of the punch  the  intention  of  conferring  benefits  and  properties  to the dosage 
Sticking  Adhesion of granulation to the die wall  form over the uncoated variety 
Unequal distribution of color on the surface of the tablet,   
Mottling   with light or dark areas standing out in an otherwise  Solid dosage forms are ​coated f​ or several reasons: 
uniform surfaces  ● To mask unpleasant taste 
  ● To protect components from atmospheric degradation 
FACTORS THAT MAY CAUSE ​SPLITTING​ ​OF TABLETS  ● To  prevent  contact  with  a  drug  which  is  irritating  or  potentially 
● Excess fines or powder with entrapped air in the tablet mixture  allergenic 
● Deep markings on tablet punches  ● To separate reactive ingredients 
● Worn and imperfect punches  ● To improve appearance 
● Worn dies  ● To control the site of drug release (​enteric coating​) 
● Too much pressure  ● To  delay  or  prolong  absorption  of  the  drug  component  by 
● Unsuitable formula  retarding  the  release  of  drug  from  the  dosage  form  (​sustained 
● Moist and soft granulation  action​) 
● Poorly machined punches  ● To  change  the  physical  surface  characteristics  of  ingredients 
  (​surface modification​) 
REMEDIES TO PREVENT​ ​PICKING​ ​or​ ​STICKING   
● Design  letterings  as  large  as  possible,  particularly  on  punches  4 Basic Categories 
with small diameters  ✓ Sugar coating 
● Reformulate to produce larger tablets  ✓ Film coating (non-enteric and enteric) 
● Plate  the  punch  faces  with  ​chromium  ​to  produce  smooth,  ✓ Compression 
nonadherent face  ✓ Other new concepts 
● Add a polishing agent such as a colloidal silica   
● Add  more  binder  or  change  the  binder  to  make  granules  more  Basic Processes Used in the Application of Coating 
cohesive  ✓ Pan coating 
● Dilution  of  low  melting  active  ingredients  or  additives  with  high  ✓ Air suspension coating 
melting  materials  will  prevent  softening  of  the  granules  due  to  ✓ Dip coating 
heat of compression and may increase tablet size  ✓ Tablet compression coating 
● Refrigeration  of  the  press  and  granulation  containing  high   
concentration of low melting medicament     
● Redry the granulation 
 
 
 
 
 
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Pan Coating  Involves several basic steps: 
↳ Most widely used by the industry  SEALING  
↳ Process is used in both sugar and film coating  ➜ Done  to  separate  the  core  from  the  water  that  is  used  in  the 
↳ Makes  used  of  coating  pans  provided  with  hot  and  cold  air  coating process 
input  system  and  an  exhaust  system  to  remove  moisture  and  ○ Waterproofing materials  
fine powder generated during the coating operation  ↳ Such  as  ​cellulose acetate phthalate​, ​zein​, ​shellac and 
↳ Other  necessary  equipment  includes  stem  jacketed  tanks  for  specific resins  
the  preparation  of  liquids  used,  drying  ovens  necessary  in  the  ↳ Are​ adhesive i​ n nature. 
process and polishing drums  ○ Dusting compounds  
  ↳ Such as a ​ sbestos-free talc​ and t​ erra alba  
Air Suspension Coating  ↳ Are  applied in between 2 seal coats up to 6 seal coats 
↳ Most dependable methods for applying film coats  to  prevent  the  tablets  from  sticking  with one another 
↳ Film  material  is  atomized  and  applied  to  tablets  as  they  are  and to the coating pan. 
suspended  inside  the  columnar  coating  chamber  by  means  of   
a stream of hot air  SUBCOATING  
↳ Major  problem  associated  with  air  suspension  coater  is  ➜ Applied  to  round  off  the  tablet  contour  rapidly,  to  improve  the 
BREAKAGE  bond  between  the  seal  coat  and  sugar  coat,  and  to  build  up  or 
↳ As  the  tablets  travel  up  the  center  of  the  column  in  the  main  standardize tablet size. 
stream,  velocities  are  so  high  that  collisions  between  tablets  ○ Solutions  used  to  subcoat  are  usually  ​gelatin  and/or 
and  the  wall  of  the  coating  chamber  may  produce  excessive  acacia​. 
tablet breakage.    
○ Therefore,  it  is  essential  that  tablets  to  be  subjected  to  SYRUPING  
this  process  be  formulated  for  minimum  friability  and be  ➜ Syrup  coating  and  dyeing  phase  of  the  process  is  particularly 
strong enough to withstand the coating conditions  demanding 
  ➜ It usually involves​ 3 basic phases​:  
Dip Coating  ○ Grossing 
↳ Has  not  been  widely  accepted  (in  the  pharma  industry)  ○ Heavy Sugar Coating  
because  of  difficulties  encountered  during  coating  procedure  ○ Regular Syrup Coating 
and lack of coat uniformity   
○ But it is used in the food industry (eg. keso de bola)  FINISHING  
↳ Materials  to  be  coated  are  usually  placed  in  baskets  and  ➜ Initiated when the desired color is attained 
dipped  into  containers  of  coating  solutions. The wet tablets are  ➜ Three  or  four  coats  of  regular  syrup  are  applied  rapidly  without 
then  agitated  or  tumbled  in  coating  pans  during  drying  to  permitting the tablet bed to become dusty 
prevent  adherence  to  each other. The process can be repeated   
a number of times after each coat is sufficiently dry.  POLISHING  
  ➜ Done  in  a  canvas  polishing  pan  by allowing the coated tablets to 
Compression Coating  roll in wax solution until high luster is produced 
↳ Makes possible some special dosage forms   
↳ Two  incompatible  drugs  may  be  separated  by  placing  one  in  PRINTING 
the core, the other in the coating  ➜ To  facilitate  identification,  usually  printed  with  manufacturer’s 
↳ Slow release formulation may be placed in a core coated with a  logo or code. 
fast  releasing granulation for immediate effect. Cores may also  ○ Printing  process  used  is  an  offset  gravure  in  conjunction 
be enteric coated for delayed release.   with edible inks. 
   
2 types of equipment have been created:  Process Details of Sugar Coating 
● One  compresses  a  coating  around  the  cores  that  have  been  ● Typically tablets are sugar coated by a panning technique 
made on another press  ● Simplest  form  would  be  a  traditional  sugar  coating  pan  with  a 
● The  other  compresses  the  cores  on  one  turret  and  immediately  supply  of  drying  air  and  a  fan  assisted  extract  to  remove  dust- 
transfers them to a second for the application of the coating  and moisture- laden air 
  ● Methods  of  applying  the  coating  syrup  include  ​manually  using 
SUGAR COATING  ladle​ and ​automatic control 
➜ May be considered the traditional method of coating tablets  ● In  modern  equipment  some  form  of  automatic  control  is 
➜ Involves  the  successive  application  of  sucrose  based solutions to  available for the application of coating syrups. 
tablet cores in suitable coating equipments   
➜ Conventional  panning  equipments  with  manual  applications  of  Ideal Characteristics of Sugar Coated Tablets 
syrup  has  been  extensively  used,  although  more  specialized  ● Must  comply  with  finished  product  specifications  and  any 
equipments  and  automated  methods  are  now making an impact  appropriated compendial requirements 
on the process  ● Should  ideally  be  of  perfectly  smooth rounded contour with even 
➜ Most widely used   color coverage 
➜ If asked how many coats = ​Five (5) layer coats  ● Aesthetic appeal and high glossy appearance 
➜ If asked how many steps of sugarcoating = ​Six (6) steps  ● Any printing should be distinct, with ​no​ smudging or broken print 
   
     
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Sugar Coating Faults   
● Process  defects,  such  as  splitting  of  the  coat  on  storage, caused  Ideal Characteristics of Film Coated Tablets 
by inadequate drying during the coating application  ✓ Should display an even coverage of film and color 
  ✓ There should be NO abrasion of tablet edges or crowns 
FILM COATING  ✓ Logos and break lines should distinct and not filled in 
➜ Recent  development  which  makes  use  of  ​cellulose  polymers​,  ✓ Tablet  must  also  be  compliant  with  finished  product 
povidone  and  low  to  medium  molecular  weight  ​glycols  as  ​film  specifications and any relevant compendial requirements 
formers   
  Coating Faults 
Process Description:  ● Processing 
● Involves  deposition,  usually  by  a  spray  method,  of  a  thin  film  of  ○ Inadequate  drying  conditions  will  permit coating previously 
polymer surrounding the tablet core  deposited  on the tablet surface to stick against neighboring 
● Coating  liquid  (solution  or  suspension)  contains  a  polymer  in  a  tablets 
suitable  liquid  medium  together  with  other  ingredients  such  as  ○ When  parted,  this  will  reveal  the  original  core  surface 
pigments​ and p ​ lasticizers  underneath 
● Solution  is  sprayed on to a rotating, mixed tablet bed or fluid bed.  ● Formulation faults 
Drying  conditions  permit  the  removal  of  the  solvent  so  as  to  ○ Film cracking or bridging of breaking lines 
leave  a  thin  deposition  of  coating  material  around  each  table   
core  Advantages of Film Coating in place of Sugar Coating 
  ✓ Reduction in coating time and material cost 
✓ No significant increase in tablet weight 
SUBSTANCES IN THE FILM COATING SUSPENSION FORMULATION 
✓ No undercoat or waterproof coat required 
Cellulose derivatives  ✓ Durability and resistance to chipping and cracking 
POLYMER  - Hydroxypropyl methylcellulose  ✓ Allows monogramming identification of product 
- Methacrylate amino ester copolymers 
✓ Proves effective protection to light, air, and moisture 
PEG 400  ✓ No adverse effect on disintegration time 
PLASTICIZERS  Organic esters (diethyl phthalate)  ✓ Pharmaceutically elegant 
Oils/glycerides (fractionated coconut oil) 
✓ Provides the opportunity to use non-aqueous coating solutions 
Iron oxide pigments  ✓ Standardization of process and materials 
COLORANTS  Titanium dioxide 
 
Aluminum Lakes 
SOLVENT  Organic solvents  MAJOR DIFFERENCES BETWEEN SUGAR AND FILM COATING 
  Features  Sugar coating  Film coating 
DISADVANTAGES OF ORGANIC SOLVENTS FOR THE PROCESS  Retains contour of 
Rounded with high  original core. 
Venting of untreated organic solvent vapor into  Appearance  
Environmental  degree of polish  Usually NOT as shiny 
the atmosphere is ecologically unacceptable  as sugar coat types 
Organic solvents provide explosion, fire, and toxic  Weight increase due 
Safety  30-50%  2-3% 
hazards to plant operators  to coating materials 
Expensive  Logo or break lines  Not possible  Possible 
Financial 
Use of organic solvents 
Coating of 
Necessitates the building of flame and explosion proof facilities  Coating possible but 
Other solid dosage  multiparticulates very 
little industrial 
Solvent  For a given process the amount of residual  forms  important in modified 
importance 
Residues  organic solvent in the film must be investigated  release forms 
  Multistage process  Usually single stage 
Stages 
Equipment Suitable for Film Coating  (​6​ stages)  (​1​)  
Accela Cota  UK  Typical batch  8 hours or more,  
1.5 - 2 hours 
coating time  but usually longer 
Hi Coater  Japan 
Not usually possible 
Driacoater  Germany  Easily adaptable for 
Functional coatings  apart from enteric 
controlled release 
HTF/150  Italy  coating 
IDA  France   
These are brands and their place of manufacturer  OTHER TYPES OF COATING 
  ● Compression coating 
Basic Process Requirements for Film Coating  ● Electrostatic coating 
● Adequate  means  of  atomizing  the  spray  liquid  for  application  to  ● Laminated coating 
the tablet cores   
● Adequate mixing and agitation of the tablet bed  Compression Coating 
● Sufficient  heat  input in the form of drying air to provide the latent  ➜ Makes  use  of  sophisticated  tablet  compression  machine  which 
heat of evaporation of the solvent   compresses  a  coating  or  shell  around  a  core  that  has  been 
● Good exhaust facilities to remove dust- and solvent laden air  compressed on another press 
   
     
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Electrostatic Coating 
➜ Employed  to  apply  films  to conductive materials by imparting an 
ionic  charge  ​to  the  substrate  and  an  ​opposite  charge  ​to  the 
coating materials​. 
○ This ensures a thin and continuous film to the surface. 
 
Laminated Coating 
● Provides a second action or layer of medicament for the tablet as 
in: 
 
1. A r​ epeat action​ tablet,  
↳ In  which  a  portion  of  the  drug  is  in  the  outer  lamina  or 
coating 
2. Enteric tablets​,  
↳ In  which  one  drug  may  be  made  available  for  ​gastric 
absorption  and  another  (or  more  of  the  same)  is  released 
in the ​intestine 
3. Buccal-swallow tablet 
↳ Which  is  administered  first  sublingually,  and  upon  a  signal, 
such  as  release  of  a  flavor  from  the  inner  core,  tablet  is 
swallowed  and  proceeds  to  disintegrate as normal per oral 
tablet 
 
 
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Powders are most commonly prepared by 
OTHER SOLID DOSAGE FORMS Divided Powders  
POWDERS  ↳ Dispensed  in  the  form  of  individual  doses  and  packed  in 
➜ Early  dosage  form  of  crude  drugs  and  other  natural  products  papers,  properly  folded,  pouches  made  of  metal  foil,  small 
were administered in the form of powders  heat-sealed plastic bags or other containers 
➜ Its  popularity  declined  with  lessened  use  of  the  crude  drugs  and   
increasing use of highly potent compounds  Bulk Powders 
  ↳ Mixed  with  water  or  other  suitable  material  prior  to 
2 Advantages  administration 
✓ Flexibility in compounding  ↳ Classified as: 
✓ Relatively good chemical stability  ○ Oral powders 
  ○ Dentifices 
Disadvantages of using Powder  ○ Douche powder 
✓ Time consuming to prepare  ○ Dustin powders 
✓ Not  well  suited  for  the  dispensing  of  many  unpleasant-tasting,  ○ Insufflations 
hygroscopic or deliquescent drugs  ○ Trituration 
✓ Inaccuracy of dose when in the form of bulk powders   
  CAPSULES 
SMALL SCALE MANUFACTURING IS PREPARED BY ONE OF THE  ➜ Solid  dosage  forms  in  which  the  drug  substance  in  enclosed  in 
FOLLOWING METHODS  either  hard  or  soft  soluble  container or shell of a suitable form of 
Trituration  gelatin 
↳ Process  of  reducing  substances  to  fine  particles  by  rubbing  ➜ Source of gelatin for capsules is ​pork’s skin 
them in a mortar with a pestle  ➜ USP  specification  for  the  source of gelatin for capsules 一 ​partial 
○ Mortar & Pestle ー Both for mixing & blending  hydrolysis of collagen 
   
Types of mortar & pestle:  Capsules are popular for the following reasons: 
● Wooden  ✓ Tasteless and are easily administered 
● Porcelain  ✓ Easily  filled  either  extemporaneously  or  in  large  quantities 
● Glass  commercially 
  ✓ Permit flexibility and exact dosage level 
Pulverization by Intervention   
↳ Process  of  reducing  the  state  of  subdivision  of  solids  with  the  Hard Gelatin Capsules 
aid  of  an  additional  ​volatile  material  which  can  be  removed  ➜ Dry filled capsules 
easily after the pulverization has been completed  ➜ Consist  of  2  sections,  one  slipping over the other thus completely 
○ Example of volatile material:  surrounding the drug formulation in an oblong shell 
✓ Alcohol  ➜ Supplied  in  a  variety  of  sizes  numbering  000  (largest  size)  to  5 
  (smallest) 
Levigation 
000  15 grains 
↳ Process  of  first  forming  a  paste  by  the  addition  of  a  suitable 
non-solvent to the solid material  00  10 grains 
○ Example of levigating material:  0  7.5 grains 
✓ Mineral oil  1  5 grains 
  2  4 grains 
LARGE SCALE MANUFACTURING 
3  3 grains 
● Makes  use  of  high  speed  machines  for  reducing  the  size  of 
particles  of  aggregates  (eg  mills),  sieves,  screens  for  size  4  2 grains 
classification  and  distribution  and  mixers  which  produce  a  5  1 grain 
complete  blend  rapidly  with  as gentle as possible a mixing action  ➜ Made  largely  from  gelatin,  FD&C  colorant  and  sometimes  an 
to avoid product damage  opacifying agent such as titanium dioxide 
  ➜ 0.15%  of  sulfur  dioxide  ​一  added  to  prevent  decomposition 
FOLLOWING PROCEDURE SHOULD RECEIVE SPECIAL ATTENTION  during manufacture 
● Use  of  geometric  dilution  for  the  incorporation  of  small  amount  ➜ Water  content  is  ​12-16% but may vary depending on the storage 
of potent drugs  conditions 
● Reduction  of  particle  size  of  all  ingredients  to  the same range to   
prevent stratification of large and small particles  Filling  into  Hard  Gelatin  Capsules  with the Use of Hand Operated 
● Sieving  when  necessary  to  achieve  mixing  or  reduction  of  or Automatic Filling Machines includes: 
agglomerates,  especially  in  the  preparation  of  dusting  powders  ✓ Separation of cap from the boyd 
into which liquid have been incorporated  ✓ Filling of body half 
● Heavy  trituration,  when  applicable,  to  reduce  the  bulkiness  of  a  ✓ Rejoining the cap and the body halves 
powder  ✓ Cleaning of filled capsules 
● Protection  against  humidity,  air  oxidation,  and  loss  of  volatile   
ingredients     
 
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Soft Gelatin Capsules  Preparation of Suppositories 
➜ Soft,  globular,  gelatin  shell  somewhat  thicker  than  that  of  hard  ✓ Hand molding 
gelatin capsules  ✓ Cold compression 
➜ Gelation  is  plasticized  by  the  addition  of  glycerin,  sorbitol  or  a  ✓ Fusion or melt molding (pour molding) 
similar polyol  ✓ Compression in a tablet press 
○ The  shell  may  contain a preservative to prevent the growth   
of fungi  Hand Molding 
➜ Has  seam  at  the  point  of  closure  of  the  two  halves,  and  the  ↪ Simplest and oldest method for preparing suppositories 
contents can be liquid, paste or powder  ↪ No heat application 
  ↪ Well-blended  suppository  base  combined  with  the  active 
Several  Recognized  Methods  developed  for  commercial  of  Soft  ingredient  is  rolled  into  the  desired  shape  and  diameter,  and  cut 
Elastic Capsules  into appropriate length 
✓ Plate Process   ↪ Advantages  ​一  practical  and  economical  for the manufacture of 
↳ Developed by Upjohn Co,  a small quantity of suppositories 
✓ Rotary Die Process    
↳ Perfected by Robert P. Scherer  Cold Compression 
✓ Norton Capsule Machine  ↪ Cold-grated  mass  is  forced  into  a  mold  under  pressure,  using  a 
✓ Accogel Capsule Machine   wheel-operated press 
↳ Developed  by  Lederle  Laboratories  Division  of  the  ○ Pressure  is  then  released,  the  mold  removed,  opened  and 
American Cyanamid Co.  replaced 
  ↪ No heat application 
SUPPOSITORIES  ↪ On  a  large  scale,  cold  compression  machines  are  hydraulically 
➜ Solid dosage forms of various shapes and weights  operated, water-jacketed for cooling and screw-fed 
➜ Usually  medicated,  for  insertion  in  the  rectum,  vagina  or  the  ○ Pressure  is  then  applied  via  piston  to  compress  the  mass 
urethra  into mold opening 
➜ After insertion, suppositories melt or dissolve into the cavity fluids   
  Advantages of Cold Compression 
Type of Suppositories based on Site of Insertion  ✓ Method is simple 
✓ Rectal suppositories  ✓ Resulting suppository is more elegant than that of hand molding 
✓ Vaginal suppositories  ✓ Avoids  the  possibilities  of  sedimentation  of  the  insoluble  solids in 
✓ Urethral suppositories  the suppository base 
   
Rectal Suppositories  Disadvantages of Cold Compression 
↳ Tapered at one end or both resembles a torpedo  ✓ Too slow for large scale operations 
Infants  1 gram  ✓ Air entrapment in molding fat type base suppositories 
 
Adults  2 grams 
Fusion or Melt Molding 
 
↪ Also known as Pour Molding 
Vaginal Suppositories 
↪ Most  commonly  used  for  producing  suppositories  on  both  small 
↳ Usually  globular  or  oviform,  conical  or  almond as in compressed 
and large scale operation 
tablets 
↪ The  base  material is melted, preferably on a water or steam bath 
↳ About 3-5 grams 
to avoid local overheating 
 
○ Active ingredients are either emulsified or suspended in it 
Urethral Suppositories 
○ The mass is then poured into cooled metal molds, which are 
↳ Pencil-shaped and pointed at one extremity 
usually chrome or nickel-plate 
4 grams  ↪ The  suppositories  and  mold  are allowed to cool thoroughly using 
Males 
100 - 150 mm long 
a refrigerator in a small scale or refrigerated air on a larger scale. 
2 grams  ○ The suppositories are removed by opening the mold 
Females 
60 - 75 mm long 
 
  The Molds are Made Out of 
Ideal  Suppository  Base  should  meet  the  following  General  ✓ Aluminum alloy 
Specification  ✓ Brass 
✓ Non-toxic and non-irritating to mucous membranes  ✓ Plastic 
✓ Compatible with a variety of drugs   
✓ Melts or dissolves in rectal fluids  Capsules suppositories are usually formulated on a W ​ eight Basis 
✓ Stable  on  storage;  should  not  bind  or  otherwise  interfere  with   
release and absorption of drug substances     
 
USP List of following as usual Suppository Bases 
● Cocoa butter 
● Glycerinated gelatin 
● Hydrogenated vegetable oils 
● Mixtures of polyethylene glycols of various molecular weight 
● Fatty acid esters of polyethylene glycol 
 
 
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PHA6124​:​ ​Pharmaceutical Manufacturing Lecture 
 
Compression in a Tablet Press   
Carbon Dioxide-releasing Tablet  Hard Candy Base 
↪ Made  up  of  dried  sodium  biphosphate,  sodium  bicarbonate  and  ↪ For heat stable active drug 
starch  ↪ Syrup  is  concentrated  to  the  point  where  it  becomes  a  pliable 
↪ This  compressed  rectal  suppository  is  dipped  in  or  sprayed  with  mass,  the  active  ingredient  is  added,  and  the  mixture is kneaded 
thin  coating  of  water-soluble  PEG  to  add  an  external  film  for  while warm to form a homogenous mass 
protection of the core and for air in insertion into the rectum  ○ The  mass  is  gradually  worked into a pipe form or rope and 
  passed  through  a  drop  former  where  lozenges are cut into 
Vaginal Compressed Tablet  the desired shape and allowed to cool 
↪ In  the  addition  to  the  active ingredient, it contains lactose and/or   
anhydrous  dextrose  as  excipients  and  boric  acid  and/or 
phosphoric  acids  for  adjusting  the  acidity  of  the  vagina  to  an 
approximate pH 5 
 
Packaging & Storage 
✓ Must  be  packaged  in  such  a  way  so  that  they do not touch each 
other 
✓ If  not  individually  overwrapped in aluminum foils, they are placed 
in  cardboard  boxes  or  plastic  containers  with  individual 
compartments 
✓ Because  of  hygroscopicity,  ​glycerin  and  ​glycerinated  gelatin 
suppositories are often packed in tightly closed screw cap bottles 
✓ Most  recent  and  elegant  way  of  packing  suppositories  is  by  the 
use of ​disposable molds 
✓ Suppository  Melts  are  molded  directly  into  individual  aluminum 
or  plastic  wrapping  materials  made  up  of  polyvinyl  or 
polyethylene 
○ These are attached by stripping material 
○ Units are sealed and cut/divided into the desired number 
○ They are subsequently packed in cartoons. 
✓ Suppositories  with ​low melting point are stored in a cool place or 
kept in a refrigerator 
 
TROCHES (LOZENGES OR PASTILLES) 
➜ Discoid  shaped solids containing the medicinal agent in a suitably 
flavored base 
➜ Placed  in the mouth where the active ingredient is released as the 
troches dissolve slowly 
➜ Main ingredients are classified into: 
○ Active drugs 
↳ such  as  antiseptic,  local  anesthetic,  antibiotic, 
antihistamine, antitussive, analgesic, decongestant 
○ Flavored base  
↳ Hard  sugar  candy,  glycerinated  gelatin,  combination 
of sugar and sufficient mucilage to give it form 
 
Large  Scale  Commercial  Procedures  make  use  of  the  following 
methods (Troches) 
● Compression (heat labile active ingredients) 
● Hard Candy Base (heat stable active ingredient) 
 
Compression 
↪ Granulation  is  prepared  in  a  manner  similar  to  that  used for any 
compressed tablet 
○ The  lozenge  is  made  using  heavy  compression  equipment 
to  give  a  tablet  which  is  harder  than usual as it is desirable 
for  the  troche  to  dissolve  or  disintegrate  slowly  in  the 
mouth 
↪ Heat labile active ingredients 
 
 
 
 
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Laboratory 
 
2) Absorption Bases 
SEMI-SOLID DOSAGE FORMS
↳ Anhydrous and water insoluble 
OINTMENTS 
↳ Not washable in water, although they can absorb water 
↳ Semisolid preparations intended for external use 
↳ These  bases  water-soluble  medications  to  be  included 
↳ Easily spread 
through prior solution and uptake as the internal phase 
↳ Modifying the formulation controls their plastic viscosity 
 
 
Examples of Absorption Bases 
Ointments are typically used as… 
Wool Fat 
● Emollients to make the skin more pliable 
↳ Anhydrous Lanolin 
● Protective  barriers  to  prevent  harmful  substances  from 
↳ Contains  a  high  percentage  of  cholesterol  as  well  as 
coming in contact with the skin 
esters and alcohol that contain fatty acids 
● Vehicles (or base) in which to incorporate medication 
↳ It  absorbs  twice  its  weight  in  water  and  melts  between 
 
36-42ºC 
CLASSIFICATION OF OINTMENT BASES 
 
1) Oleaginous Bases 
Hydrophilic Petrolatum 
↳ Hydrocarbon bases 
↳ Wet  petrolatum  combined  with  ​8%  beeswax​,  ​3%  stearyl 
↳ Anhydrous and insoluble in water 
alcohol​ and 3​ % cholesterol 
↳ Cannot  absorb  or  contain  water  and  are  not  washable  in 
○ These components are added to a w/o emulsifier 
water 
↳ Prepared forms include: 
 
○ Aquaphor (​ brand name) 
Examples of Oleaginous Bases 
↪ Uses  wool  alcohol  to  render  white  petrolatum 
Petrolatum 
emulsifiable 
↳ Good base for oil insoluble ingredients 
↪ A superior in its ability to absorb water 
↳ Forms an occlusive film on the skin 
 
↳ Absorbs <5% water under normal condition 
3) Emulsion Bases 
↳ Does not become rancid 
↳ May  be  ​w/o  emulsions​, which are water insoluble and are 
↳ Wax can be incorporated to stiffen the base 
not washable in water 
 
○ These  emulsions  can  absorb  water  because  of  their 
Synthetic Esters 
aqueous internal phase 
↳ Used as constituents of oleaginous bases 
↳ Emulsion  bases  may  also  be  ​o/w  emulsions​,  which  are 
↳ Examples: 
water insoluble but washable in water 
○ Esters  include:  glyceryl  monostearate,  isopropyl 
○ They  can  absorb  water  in  their  aqueous  external 
myristate,  isopropyl  palmitate,  butyl  stearate,  and 
phase 
butyl palmitate 
 
○ Long  chain  alcohols  (e.g.  cetyl  alcohol,  stearyl 
Examples of Emulsion Bases 
alcohol, PEG) can also be used 
Hydrous Wool Fat 
 
↳ Lanolin 
Lanolin Derivatives 
↳ W/O emulsion that contains approximately 25% water 
↳ Often used in topical and cosmetic preparations 
↳ Acts as an emollient and occlusive film on the skin 
↳ Examples:​ Lanolin oil and Hydrogenated Lanolin 
↳ Effectively preventing epidermal water loss 
 
 
 
Cold Cream 
 
↳ W/O  emulsion  that  is  prepared  by  melting  white  wax, 
 
spermaceti,  and  expressed  almond  oil  together;  adding  a 
 
hot  aqueous  solution  of  sodium  borate,  and  stirring  until 
 
the mixture is cool 
 
↳ The  use  of  ​mineral  oil  rather  than  almond  oil  makes  a 
 
more stable cold cream 
 
○ However,  cold  cream  prepared  with  ​almond  oil 
 
makes a better emollient base 
 
↳ This ointment should be freshly prepared 
 
   
 

 
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PHA6124​:​ ​Pharmaceutical Manufacturing Laboratory 
 
Hydrophilic Ointment  COMPENDIAL REQUIREMENTS FOR OINTMENT 
↳ O/W  emulsion  that  uses  ​sodium  lauryl  sulfate  as  an  ● Microbial Content 
emulsifying agent  ● Minimum Fill 
↳ Absorbs 30-50% w/w without losing its consistency  ● Packaging, Storage, and Labeling 
↳ Readily  miscible  with  water  and  is  removed  from  the  skin  ● Sterility  and  Metal  Particles  Content  for  Ophthalmic 
easily  Ointment 
   
Vanishing Cream  ANTIMICROBIAL PRESERVATIVES IN TOPICAL PREPARATIONS 
↳ O/W emulsion  ● Methyl parabens 
↳ Contains  large  percentage  of  water as well as ​humectant  ● Propyl parabens 
(e.g. glycerin, propylene glycol) that retard moisture loss  ● Phenols 
↳ An  excess  of  stearic  acid  in  the  formula  helps  form  a thin  ● Benzoic acid 
film when the water evaporates  ● Sorbic acid 
  ● Quaternary Ammonium Salts 
Other Emulsion Bases   
↳ Dermovan, hypoallergenic, greaseless emulsion base  CREAMS 
↳ Unibase,  non-greasy  emulsion  base  that  absorbs  ↳ Semisolid  preparations  containing  one  or  more  medicinal 
approximately  30%  of  its  weight  in  water  and  has  a  pH  agents  dissolved  or  dispersed in either a water in oil (w/o) 
close to that of the skin  emulsion  or  an  oil  in  water  (o/w)  or  in  another  type  of 
  water washable base 
4) Water Soluble Bases  ↳ Many  patients  and  physicians  prefer  cream  to  ointments 
↳ Anhydrous or may contain some water  because they are easier to spread and remove 
↳ Washable  in  water  and  absorb  water  to  the  point  of  ↳ Examples: C ​ old Cream, Vanishing Creams 
solubility   
  GELS 
Examples of Water Soluble Bases  ↳ Semisolid  systems  consisting  of  dispersion  of  small  or 
Polyethylene Glycol (PEG) ointment  large  molecules  in  an  aqueous  liquid  vehicle  rendered 
↳ Blend  of  water  soluble  polyethylene  glycol  that  form  a  jelly-like by the addition of a gelling agent 
semisolid base  ↳ Examples of Gelling Agents: 
↳ Can  solubilize  water  soluble  drugs  and  some  water  ○ Synthetic Macromolecules (carbomer 934) 
insoluble drugs  ○ Cellulose  Derivatives  (carboxymethylcellulose  or 
○ It is compatible with a wide range of drugs  hydroxypropyl methyl cellulose) 
↳ Contains 40% PEG 3350 and 60% PEG 400  ○ Natural Gums (tragacanth) 
○ Prepared by Fusion Method  ↳ Also known as Jellies 
↳ Only  a  small  amount  of  liquid  (<5%)  can  be  incorporated  ↳ Thixotropic property 
without loss of viscosity  ↳ It  can  be  a  Single-phase  Gels  or  2-phase  System 
○ This  base  can  be  made  stiffer  by  increasing  the  (Magmas)  
amount of PEG 3350 to 60%   
↳ If  6%  to  25%  of  an  aqueous  solution is to be incorporated,  MISCELLANEOUS SEMISOLID PREPARATIONS 
5  g  of  the 40 g of PEG 3350 can be replaced with an equal  ● Pastes 
amount of stearyl alcohol  ● Plasters 
  ● Glycerogelatins 
Propylene Glycol & Propylene Glycol-Ethanol  ● Cataplasm 
↳ Clear gel when mixed with 2% hydroxypropyl cellulose  ● Dressings 
↳ Popular dermatologic vehicle (​ ointment base)  ● Cements 
   
METHOD OF PREPARATION     
1) Levigation ​[Mechanical Incorporation] 
2) Fusion Method 
 
 
 
 
 
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PASTES   
↳ Semisolid preparations intended for application to the skin  DRESSINGS 
↳ Method  of  Preparation:  ​Mechanical  Incorporation  ​and  ↳ External  application  resembles  ointment  but  for  covering 
Fusion Methods  and protection only 
↳ For  its  ​stiffness  ​and  ​impenetrability  than  ointment  一  ↳ Petrolatum Gauze USP 
contains  ​more  solid  material  ​and  is  ​less  penetrating   
than ointment  CEMENTS 
↳ Remain  in  place  after  application  and  effectively  ↳ Frequently  used  as  dental  preparation  to  cover  up 
employed to absorb serious secretions  exposed gums or tissues 
○ Not suited for application to hairy parts of the body  ↳ Example:  
↳ Example:​ Zinc oxide paste (lassar’s plain zinc paste)  ○ Zinc Oxide Cement 
  ↪ Applied next 
PLASTERS  ↪ White “​ pasta” 
↳ Solid  or  semisolid  adhesive  masses  spread  on  a  backing  ○ Eugenol-thymol Cement 
of paper, fabric, moleskin, or plastic  ↪ Applied first to heal the inflammation 
↳ Adhesive Material​ is a rubber base or a synthetic resin   
↳ Applied  to  the  skin  to  provide  prolonged  contact  at  the  PACKAGING MISCELLANEOUS SEMISOLID PREPARATIONS 
site  Topical Dermatologic Products 
  ↳ Jars  or  tubes  for  ophthalmic,  nasal,  vagianl,  or  rectal 
Types of Plasters  semisolid products 
Non-Medicated Plasters   
↳ For protection and mechanical support (adhesive plaster)  Tubes 
  ↳ Aluminum or plastic 
Medicated Plasters  ○ Plastic Tubes 
↳ Provide effects at the site of application  ↪ Are  made  of  high  or  low  density  polyethylene 
↳ i.e. Salicylic acid plaster, Chili plaster  (HDPE or LDPE) or a blend of each 
  ↪ Polypropylene  (PP),  Polyethylene  terephthalate 
GLYCEROGELATINS  (PET) 
↳ Plastic  masses  containing  gelatin  (15%),  glycerin  (40%),  ↪ Various plastic, foils and paper laminates 
water (35%) and added medicinal substance (10%) such as   
zinc oxide  PACKAGING SEMISOLID PREPARATIONS 
↳ Prepared by:  Packaging: Jars o​ r ​Tubes 
○ Softening the gelatin in the water (steam bath)  ● Ophthalmic, Nasal, Vaginal, and Rectal semisolids 
○ Adding the medicinal substance mixed with glycerin   
○ Allowing to cool with stirring until congealed  Ointment Jars = clear or opaque glass or plastic 
↳ Applied to the skin for long term  Ointment Tubes = aluminum or plastic 
○ Melted  before  application,  cooled  to  slightly  above  lol check book for Filling of these packaging 
body temperature   
○ Applied to the affected area with fine brush     
○ Following  application,  the  glycerogelatin  hardens,  is 
usually  covered  with  bandage  (allowed  to  remain  in 
place for weeks) 
↳ Zinc Gelatin boot ​(varicose ulcers) 
↳ Starch glycerite​ (protectant) 
 
CATAPLASM 
↳ Also known as Poultice 
↳ Natural product 
↳ Heated first with oil before applying on skin 
↳ Gumamela Poultice​ for boils 
 
 
 
 
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FEATURES AND USE  
 
DERMATOLOGIC PREPARATIONS 
● Skin  is  divided  histologically  into  stratum  corneum, 
epidermis, and dermis 
● Treating skin diseases 
○ The  drug  in  medicated  applications  should  penetrate 
and be detained in the skin for a while 
● Prescription or OTC 
○ We  should  be  certain  that  the  patients understand the 
proper  method  of  administration,  frequency  and 
duration  of  use,  special  warnings,  therapeutic  goals 
and  anticipated  outcomes,  adverse  effects,  allergic 
sensitivity  reactions,  treatment  failure  and  reasons  for 
discontinue  treatment  and  seek  further  professional 
guidance  
 
OPHTHALMIC OINTMENTS & GELS 
● Used  topically  for  the  treatment  of  conditions  and diseases 
of the eyes 
● Applications  of  medication  to  the  eye  or  conjunctival  sac 
affects  the  surface  of  the  eye  and  underlying tissues as the 
drug penetrates 
● Sterility test and metal particles test 
● Pack in collapsible ointment tubes 
 
NASAL OINTMENTS & GELS 
● Used for topical treatment of the nasal mucosa 
● Drugs  introduced  into  the  nasal  passage  are  primarily  for 
local  effects  on  the  mucous  membranes  and  underlying 
tissues 
 
RECTAL PREPARATIONS 
● Used in the topical treatment of anorectal conditions 
● Topical  applications  to  the  perianal  area  and  for  insertion 
within the anal area 
● Local  conditions  of  anorectal  pruritus,  inflammation  and 
pain and discomfort associated with hemorrhoids 
● Astringents, Protectants, Lubricants, Local Anesthetics 
● Pack with special perforated plastic tips 
● Rectal  Aerosol  Foam  ​products  are  accompanied  by 
applicators to facilitate administration 
 
VAGINAL PREPARATIONS 
● Used  in  the  topical  treatment  of  conditions  and  diseases  of 
the vulvovaginal area 
● Used  for  the  presence  of  Trichomonas  vaginalis,  Candida 
albicans, Haemophilus vaginalis 
● Ointments, creams and gels are packed in tubes 
● Vaginal foams in aerosol canisters 
 
 

 
TIMTIMAN ​|​ 3H-PHARMACY | 2020-2021
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