Capsule:
DEFINITION:
A solid pharmaceutical dosage form
that contains medicinal agent within either a hard or soft soluble container or
shell, usually used for the oral administration of medicine. The shells are
made of a suitable form of gelatin or other substance.
OR
Capsule are solid dosage forms in which the active medicament are enclosed in either a hard or soft soluble container or shell of a suitable form of gelatin.
OR
Capsules are solid dosage forms in which drug and/or inert substances are
enclosed in a gelatin shell. The gelatin shell may be hard or soft depending on
their composition.
The word capsule is derived from the latin capsula,
meaning a small box.
Capsules are a common form of dosage for oral
administration of pharmaceutical and nutraceutical products. They are produced
in various shapes, sizes and materials, each capsule generally containing a
single dose of active ingredient. In addition to the active drug ingredient or
principal nutrient, other excipients are incorporated into the fill material,
including antimicrobial preservatives, fillers, flavouring agents, sweeteners
and colouring agent. Branding and dosage information may be printed on the
outer surface of the capsule.
Medication or ingredients inside the capsule may be in
solid, liquid or paste form, depending on the drug component or, in the case of
nutraceuticals, on the form of the main nutrient (for example liquid fish oil
is encased in the widely available fish oil capsules). The API filled in the
capsules may contain solvents or excipients but these do not affect the
integrity of the capsule shell. Other than the modified release form, no
capsule forms normally contain colouring agents.
Type of Capsule:
Hard
Gelatin Capsule
Hard gelatine capsules contain solid active ingredients.
The capsules are formed by dipping finger-shaped pin forms into liquid gelatine
solution and then extracting them and allowing the resulting surface film of
gelatine to dry out. Once the film dries, each capsule is trimmed and then
removed from the pins. The caps and body pieces of the capsule are supplied
unlocked to be filled with the appropriate drug or nutraceutical ingredients.
More than one type of drug can be encased in a
pharmaceutical capsule. In such a case, it is common to have the drugs in
different forms, e.g., one as a tablet and one as a smaller capsule. Both drugs
can then be encased in the larger capsule.
Soft
Gelatin Capsule
Soft gelatin capsules, also called soft gels, are thicker
than hard gelatin capsules and are sometimes the gelatine is plasticized by
adding glycerin or sorbitol. The thickness of the gelatin is chosen by the
manufacturer according to the requirements of the encased material and the
environmental conditions outside the capsule (e.g, air temperature and humidity).
The composition of the gelatin used to prepare soft
capsules may include preservatives, pigments and dyes. Flavourings and
sweeteners may also be added. For example sucrose may be added at a level of
about 5% to make the product palatable, and in some cases chewable. Soft gels
generally contain between 6% and 13% by weight of water.
Soft gels can be filled with liquid or solid materials
and solids can be dissolved or suspended in water to form a paste mixture. In
other cases the capsule may simply be filled with granules or powder.
Modified
Release Capsule
Both hard and soft gel capsules can be chemically
modified to control the release of the active ingredient(s). Delivery of the
active ingredient is usually effected by dissolution, degradation or
disintegration of an excipient in which the active compound is formulated. In
the case of capsules, the capsule body may be coated with a material through
which the drug diffuses. Or it may be a slowly dissolving coat that slowly
releases the drug over time. A more recent innovation is a system utilizing a
semipermeable membrane that blocks the drug from diffusing out through the
membrane, but where the water on the exterior of the membrane can diffuse into
the formulation, allowing the drug to be released through channels within the
membrane.
Enteric
Capsule
Enteric capsules are another form of modified release
capsule, and again they maybe in the hard or soft form. The encapsulating
material is designed to resist the stomach acid until it reaches the intestinal
fluid where at a higher pH it breaks down and releases the active ingredients.
It is important to observe during the manufacturing,
packaging, storing and distribution of capsules that microbial contamination is
possible as the capsules made of gelatine are susceptible to microbial attack
and growth.
ADVANTAGES:
- They obscure the taste and odour of unpleasant drug.
- They are attractive in appearance.
- They are slippery when moist and hence, easy to swallow with a draught of water.
- If properly stored the shells contain 12-15% of moisture which give flexibility and consequently very considerable resistance to mechanical stresses.
- Less adjuncts are necessary than tablets.
- The contents are usually in fine powder which combined with adjuncts provides rapid and uniform release of medicament in the GIT.
- The shells can be opacified with Tio2 or coloured to give protection from light.
- The shells are physiologically inert and easily and quickly digested in the GIT.
- Presentation of a drug in capsule rather than in tablets, allows quicker submission of a new drug for clinical trial because fewer development problem are involved. Also it is easier to vary the dose.
Dis advantage of capsule dosage form:
- Capsule are not suitable for liquids that dissolve gelatin. Such as aqueous or hydroalcoholic solution.
- The concentrated solutions which required previous dilution are unsuitable for capsules because if administered as such lead to irritation into stomach.
- Not useful for efflorescent or deliquescent materials. Efflorescent cause capsules to soften & deliquescent may dry the capsule shell to brittleness.
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