Lecture 5: Capsules Flashcards
Capsules
-solid
-AI enclosed in small shell
Hard-shelled capsules
-for dry, powder ingredients
-gelatin capsules
-polymer capsules
soft-shelled capsules
-for liquids and AIs dissolved or suspended in liquid
Gelatin capsules
-gelatin, sugar, water, color
-13-16% moisture
-packaging NEEDED to prevent issues with humidity
gelatin capsules at high humidity
-absorb moisture
-distorted and lose shape
gelatin capsules at low humidity
-lose moisture
-brittle and crumble
Polymer capsules (HPMC)
-vegetable source
-moisture only 4-6%
-more resistant to change in humidity
Prep of hard gelatin capsules
-prep formulation and select capsule size
-fill shells
-close and seal
-clean and polish
-manual or automatic
soft capsules
-most made of gelatin
-may have preservative
-can be solution or suspension
-sealed
water-immiscible volatile and nonvolatile liquids
-vegetable and aromatic oils
-hydrocarbons
-esters, ethers, organic acids
water-miscible nonvolatile liquids
-polyethylene glycols
-nonionic surface-active agents (polysorbate 80)
water-miscible Volatile liquids
-NOT suitable for soft gelatin capsules
-easily migrate through shell
-alcohols, ketones, acids, amines, esters
Advantages of soft capsules
-drug can be liquid
-dose precision
-more homogeneity
-drug dissolved so it rapidly releases
Disadvantages of soft capsules
-some drugs may migrate to shell
-some drugs can degrade in liquid state
Capsule regulation
-added substances
-containers for dispensing
-disintegration test
-dissolution test
-weight variation (hard vs soft)
-content uniformity and labeling
-stability testing
-moisture permeation
Regulations of added substances in capsules
-harmless in used quantities
-do not exceded minimum amounts required to provide unintended effect
-do not impair product’s bioavailability, theraputic efficacy, safety
-do not interfere with requisite assays and tests
Containers for dispensing capsules
-tight
-well-closed
-light-resisitant
Disintegration test for capsules
-basket rack assembly
-37degree water
-disintegrate completely into a soft mass with no firm core and only some fragments of the gelatin shell
Dissolution test for capsules
-paddle method
-basket method
content uniformity of capsules
-9/10 within 85-115%
-none outside of 70-125% label claim
-additional testing required if they are outside
Content labeling requirement of capsules
-must be labeled to express quantity of each active ingredient in each dosage unit
Stability testing of capsules
-intrinsic stability of drug
-environmental factors
Moisture permation test of capsules
-package together with color-revealing desiccant pellet
-exposing the packaged unit to known relative humidity over specified time
-observe desiccant pellet for color change (moisture absorption)
-compare pretest and posttest weight
