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Pharmaceutical ApplicationTablets and Capsules
Yoshiko Katori
CE457_527
Colloid and Surface Phenomena
Spring 2004
Overview
• Introduction• Tablets and capsules• Composition and Manufacture Process• Applications
Tablets and Capsules
• Pharmaceutical market over $280 billion• Supplements market $17.7 billions
http://www.concerta.net
How the medicine works
Mouth
Stomach
Small Intestine
• Ingest tablets or capsules from the mouth
• Dissolve in the stomach or the small intestine
• Absorb into the blood stream via small intestines
• Go through the entire body• It only works where the pain is.
Tablets and Capsules
• Tablets• Regular • Chewable• Dissolvable in water
• Capsules• Hard capsules• Soft capsules
www.aspirin.com, www.advil.com
Tablets
1-10%Binder(Polyvinilpyrrolidone)
0.1-20%Surfactant(SDS, Pluronic)
Active substance
Manufacture ProcessTablets
http://www.dekker.com
Filling
Punch
Die
Compression
Punch
Ejection
Tablet
coating
Hard Capsule
30%Gelatin
65%Water
5%Dye
0.1-0.5%1-2%
Surfactants(sodium docusateSodium lauryl sulfate)
Speed up DissolutionBy increasing the wetting of powder
Manufacture ProcessHard Capsules
Dipped into gelatin solution Dried Stripped off Combined
http://www.rjengineering.com
Filling is a separate process.
Soft capsule
40-45%Gelatin
20-30%Water
5%Dye
30-35%PlasticizerPropylene glycol, sorbitol, glycerin
Manufacture ProcessSoft Capsules
http://www.asojsoftcaps.com/technology.htm
1. Gelatin Ribbon2. Rotary die3. Filling capsule4. Filled capsule5. Webbing6. Pumping mechanism
Comparison
YesYesYesEasy to swallow
GoodGoodPoorBioavailability
CostlyCostlyCheapPrice
StableLess impurities
Brittle or get stickyhumidity control required
Relatively stable
Stability
Not adaptable to incorporate mixtures
Easy to have mixtures
Layers possible
Fill
Soft CapsulesHard CapsulesTablets
Applications
Controlled Drug Delivery SystemSolvent controlled
Push Layer
Barrier Layer
Drug solution
Hard Capsule
Rate Controlling Membrane
Delivery orifice
Controlled Drug Delivery SystemSolvent controlled
Inner Layer
Osmotic Layer
Rate controlling Membrane
Delivery orifice
Soft gelatin Capsule
Liquid drug formulation
Rate controlling membrane:semi-permeable homopolymer, copolymer or polymer blend
Push layer: Expandable hydrophilic polymerpoly(hydroxyl-alkyl methyl methacrylates)Poly(vinyl pyrrolidone), poly(vinyl alcohol) etc.
Examples of Delivery Profiles possible with OROS® technology
Delivery Profiles
Delayed Drug Release
For pH sensitive drug
Enteric coating
•Not deliver drug in the stomach
• Absorb in the small intestine
PlaceboTime delayed by placeboAdsorbed in the small intestine
placebo
Capsules for Vegetarians
HPMCHydroxypropylmethyl cellulose
• Non-animal origin• Odorless, tasteless• Low moisture content • Resists physical changes at low humidity• Excellent dissolution• Chemically stable• Resistant to cross-linking• Three-year shelf life
Mad-cow disease FearReligiousPersonal preference