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solid dosage forms where the drug is encloses in either a hard shell or soft soluble container |
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- better bioavailability than tablets
- ideal for clinical trials
- elegant (pharmaceutically)
- masks bad taste/odor
- good stability
- flexible formulation |
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- unsuitable for very water soluble
- unsuitable for hydroscopic
(absorbs water from environment)
- shells are expensive |
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gelatin capsule invented in: |
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Definition
1834 by dublanc and mothes |
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Definition
hard gelatin
soft gelatin
starch capsules
hydroxylpropyl methylcellulose capsule |
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Definition
most common gelatin formulary is made from hydrolyzed collagen, animal skin, white connective tissue and bones |
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hydroxylpropyl methylcellulose |
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Definition
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ways to break down gelatin |
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Definition
A: acidic processing
B: alkali processing
A/B: blend of both |
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properties of gelatin (1) |
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Definition
1. insoluble in cold water
2. soluble in hot water/gastric fluid
3. tasteles
4. biodegradable
5. stable in dry form
6. susceptible to microbial decomposition
7. gelatin shells can be colored w/FDC approved coloring |
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capsule/gelatin properties |
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Definition
- soluble containers for solid/liquid dosage formulations
- needs appropriate amount of moisture, needs 13-16% water content
- hygroscopic drugs should be stored with dessicant |
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Park-Davis/Warner-Lamber locking mechanism -apply heat to seal cap |
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Park-Davis/Warner-Lambert locking mechanism, snaps to prevent tampering |
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Park-Davis/Warner-Lambert locking mechanism |
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Park-Davis/Warner-Lambert locking mechanism |
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Definition
Elanco/Eli Lilly lockin mechanism, snap to lock |
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Definition
Elanco/Eli Lilly locking mechanism |
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Definition
R.P. Scherer locking mechanism |
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Eli Lilly locking mechanism |
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pharmaceutic ingredients in capsules |
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Definition
diluents
lubricants
wetting agents
adsorbents |
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Definition
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microcrystalline cellulose |
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1. empty shell
2. rectification: align empty shell
3. separation: separate cap from body
4. filling: fill with drug
5. joining: place body and cap together
6. discharge: pack and go |
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what determines capsule size? |
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Definition
- amount/bulk of drug and inert substance
- age of patient, can't give 000 to old or young patient |
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extended release capsules |
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Definition
coat the pellets/granules and place in capsule |
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extemporous compounding (1) |
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Definition
filling hard gelatin capsules with combo drug, tablet or powder |
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extemporous compounding (2) |
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Definition
using hard gelatin capsule as drug source |
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soft gelatin capsule definition |
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Definition
one piece hermetically sealed(airtight) dosage form |
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components of soft gelatin shell |
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Definition
glycerin
polyhydric alchol
plasiticizer
methyl/propyl paraben
paraamino benzoic acid (preservative) |
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types of drugs inside soft gelatin capsules |
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Definition
liquids
suspensions
pasty materials
dry powder
pelletized materials |
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process of making soft gelatin capsule |
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Definition
metering pump dispenses accurate amount of drug into gelatin ribbon, gelatin ribbon is flattened by counter rotating die (die has teeth that are capsule shaped), drop of sphere gelatin capsules |
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shape of soft gelatin caspules |
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Definition
sphere
oblong
ellipse
tube-shaped |
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drug-gelatin capsule compatability |
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Definition
if the drug pH is 2.5-7.5, the pKa of the gelatin capsule must be within this range otherwise hydrolysis of the drug will occur |
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what liquids can be encapsulated in soft gelatin capsules |
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Definition
1. oil or hydrophobic liquids
2. hydrophilic polymer liquids
(polyethylene glycol PEG)
3. relatively hydrophilic nonvolatile liquids |
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Term
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Definition
natural materials, free of animal products, less susceptible to change, tamper evident |
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