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Capsule Formulation

Capsule Formulation

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Published by Farzana Shanta

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Published by: Farzana Shanta on Oct 21, 2011
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12/15/2012

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Introduction
The term capsule derived from the Latin “Capsula” meaning small box. Capsule is
a solid particle which has a size of 0.1 to 10,000 micrometer. Capsule is apharmaceutical preparation which provides different therapeutic effects based onits uses and forms.
(vinesia, 2010
)
There are various forms of capsules, including:1.
 
Based on consistency:Hard capsuleSoft capsule2.
 
Based on how to use:Per oralPer rectalPer vaginalTopical3.
 
Based on purpose of use:For animalsFor human
 Importance of capsule
I.
 
Capsule provides a tasteless or odorless dosage form without the need fora secondary coating step.II.
 
Since the shell is smooth and hydrates in the mouth so capsule easilyswallows in mouth for most patients.III.
 
Since they are available in a wide variety of colors so they are able toattract easily and are also elegance pharmaceutically.IV.
 
As suppositories some soft gelatin capsules can be administered via rectalor vaginal route.V.
 
Various sizes and shapes are available depending on the machine tools.VI.
 
Unlike tablets, capsules are filled without a compression process whichcould rupture the drug particles.VII.
 
Soft gel capsule can be manufactured in liquid dosage form which avoidsthe difficulties of poor powder flow and therefore poor content uniformity.
 
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VIII.
 
Packaging in well designed blister packs using materials of low moisturetransmission drug can be protected from moisture.
IX.
 
Capsule, especially liquid filled sift gel capsules are proved to be beneficialbecause they are less subject to oxidative or hydrolytic degradation.
(
According to Banker (2002) and according to Aulton (2002) )
Formulation Challenges
During capsule formulation some problems arises which create harmful effect onproduct. There are the following problems that can be considered as formulationchallenges of capsule formulation
Powder flow ability problem:
the final mixture of capsule may not have goodpowder flow ability which do not ensure delivery of sufficient powder to thecapsule during filling operation and thus affect uniform dosing.Sometimes there is remixing during powder handling in the filling equipmentitself.
Physical Incompatibilities:
there may be physical incompatibilities between activeingredients and diluents or between active ingredients and/or diluents and thecapsule shell.
The Vulnerability Problem:
the vulnerability of capsule may caused by theingredients that are hygroscopic which damage capsule wall. The damage occursdue to easy melting or absorption of water or moisture.
Being Soften:
capsules can be soft, even sticky due to the lower melting point of mixed material or compounds.
Damage of Shell:
capsule shell can be damaged by volatile oils such as creosoteand alcohol.
(vinesia, 2010)
Solution of the Challenges
 
Solution of Flow Ability:
the following ingredients may be considered for theimprovement of flow ability
 
Glycol esters
 
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Silicons
 
Silicon dioxide
 
Metallic stearates
 
Stearic acid
 
Talc
Fig: talc(tootoo.com. accessed 4-10-2011)
 
fig: silicon
 For improving cohesiveness inert, edible and FDA-approved oils can be used.
Solution of Incompatibility:
incompatibility can be avoided by using qualityfulingredients by checking and re-checking them.
Solution of Hygroscopicity:
addition of an inert material, such as lactose,mannitol or starch overcomes hygroscopicity.
Solution of Softness:
this problem can be overcome by adding an inert materialor by entering each ingredient in a small capsule, then the two materials areincorporated into a larger capsule.Another way to solve this problem is the usage of adsorbant as a filling toseparate elements. When these elements contacts they absorb the material thatcan be melted.Examples include magnesium carbonate, kaolin or magnesium oxide light (used< 120 mg per capsule)
Fig: kaolin (hiwte.com, accessed 5-10-2011)

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