Consists of a 2 piece hard gelatin shell, with a powder blend. Typical formulation would be:-
Active
Diluent
Glidant
Lubricant
Wetting agent
Capsules have advantages as oral dosage forms:
Easy to administer, simpler formulations (v’s tablets-fewer stability problems)
Taste/odour masking
Potentially good bioavailability
Liquid filled capsules –Advantages
1. Dose Uniformity
In a powder capsule for potent drug choice the problems are achieving homogenous mix at the required scale of scrutiny. To overcome this problem we could formulate as a solution; 100% homogenous.
Filling liquids also avoids problems of poor powder flow; if this occurs during filling, can lead to variation of fill weight. (with a liquid,cV< 1% possible) .
2. Patient safety compliance/consumer preference
Softgel capsule shel soft/flexible; popular dosage form, due to ;
Ease of swallowing
Absence of taste
Convenience (portable, robust)
Soft gels capsules can be formulated to be taken in different ways;
Chewable or lozenges
Twist-offs (with a tag allows access to contents)
3. Increased Bioavailability
Dissolution of drug from solid state (i.e formulated as an ordinary tab/cap) can be rate limiting step. This often true for non-polar drugs.
But in liquid fill cap, drug is in a form from which it can be absorbed rapidly.
Drug being in solution has additional advantage (i.e v’s tablet, fro low solubility drug)
Reduces variability of drug plasma levels (between patients) 4. Safety
Powder processing of very potent or cytoxic drug hazardous; dust contamination avoided by solution. 5. Oily/low melting point drugs
Diffilcult to make into “ normal” tab/cap (drug could partly melt during compression) 6. Product stability
Drug can be protected against O2/H2O by using lipid vehicle and soft gel shell.
Considerations for Capsule shell
Having liquid in direct contact with the shell –more potential for formulation