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Page 1 of 8 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 a pharmaceutical preparation which provides different therapeutic effects based on its uses and forms. (vinesia, 2010) There are various forms of capsules, including: 1. Based on consistency: Hard capsule Soft capsule 2. Based on how to use: Per oral Per rectal Per vaginal Topical 3. Based on purpose of use: For animals For human

Importance of capsule I. II. III. IV. V. VI. VII. Capsule provides a tasteless or odorless dosage form without the need for a secondary coating step. Since the shell is smooth and hydrates in the mouth so capsule easily swallows in mouth for most patients. Since they are available in a wide variety of colors so they are able to attract easily and are also elegance pharmaceutically. As suppositories some soft gelatin capsules can be administered via rectal or vaginal route. Various sizes and shapes are available depending on the machine tools. Unlike tablets, capsules are filled without a compression process which could rupture the drug particles. Soft gel capsule can be manufactured in liquid dosage form which avoids the difficulties of poor powder flow and therefore poor content uniformity.

Page 2 of 8 VIII. Packaging in well designed blister packs using materials of low moisture transmission drug can be protected from moisture.

Capsule, especially liquid filled sift gel capsules are proved to be beneficial because 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 on product. There are the following problems that can be considered as formulation challenges of capsule formulation Powder flow ability problem: the final mixture of capsule may not have good powder flow ability which do not ensure delivery of sufficient powder to the capsule during filling operation and thus affect uniform dosing. Sometimes there is remixing during powder handling in the filling equipment itself. Physical Incompatibilities: there may be physical incompatibilities between active ingredients and diluents or between active ingredients and/or diluents and the capsule shell. The Vulnerability Problem: the vulnerability of capsule may caused by the ingredients that are hygroscopic which damage capsule wall. The damage occurs due 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 creosote and alcohol. (vinesia, 2010) Solution of the Challenges Solution of Flow Ability: the following ingredients may be considered for the improvement of flow ability Glycol esters

Page 3 of 8 Silicons Silicon dioxide Metallic stearates Stearic acid Talc

Fig: talc( 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 qualityful ingredients 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 material or by entering each ingredient in a small capsule, then the two materials are incorporated into a larger capsule. Another way to solve this problem is the usage of adsorbant as a filling to separate elements. When these elements contacts they absorb the material that can be melted. Examples include magnesium carbonate, kaolin or magnesium oxide light (used < 120 mg per capsule)

Fig: kaolin (, accessed 5-10-2011)

Page 4 of 8 Solution of Damaging of Shell: volatile oil or alcohol which may caused damage of shell must be diluted first with fatty oils to level below 40% before the insertion into the capsule. (vinesia, 2010) , (Lachman et al, 1987)

Advantages and Disadvantages of Capsule Advantages Capsule is an uniform dosage form and has good better delivery ability Depending on the patient needs hard gel or soft gel capsules can be administered Capsule dosage form out of compress procedure which hampers active ingredients Since capsule is small in size so dissolution and absorption is better than tablets or pills Capsule can be manufactured as sustained release dosage form Capsule avoids cross contamination and airborne dust which happens for tablet manufacturing during milling and compression of granules. (vinesia,

Disadvantages There are some ingredients such as potassium chloride, potassium bromide, calcium chloride which are not suitable for encapsulation because these are very soluble. Besides when capsule is broken inside the body these ingredients come in contact with the stomach wall and cause stomach irritation and stomach becomes tense. Very efflorescent or deliquescent materials cannot be used in capsule. Capsule becomes soft by using efflorescent material and becomes brittle when deliquescent materials are used. If capsule is bitter in taste it causes vomiting and corrosive which are difficult to overcome. Capsule manufacturing takes a long compounding process. (vinesia, 2010)

Page 5 of 8 Recent Advancement of Capsules Now a days there are upgraded developments in capsule formulations.
(thefreelibrary, 2007)

Some recent advancements in capsule formulation are stated


New materials Gelatin is the main capsule forming material and alternative of it is developing. Recently non-gelatin soft gels are developing in which there is modified starch in combination with carrageenans. These are derivative of sulphated polysaccharides obtained from the cell walls of red algae. Two types of carrageenans o o Kappa carrageenan which provides gel strength Iota carrageenan which provides flexibility of capsule

An well established alternative of gelatin for capsule manufacture is Hydroxypropylmethyl cellulose (HPMC). In the European Union it was classified as organic on January 2007. Formulation components Through micro-emulsion systems and methods of use lipid based materials such as linoleolyl, lauroyl and oleoyl macrogol glycerides have shown improved bioavailability. These materials are thermodynamically stable and improve bioavailability of low solubility and low permeability compounds. New presentations Duocap system has developed for multi-component and multi-phase products. It can solve the formulation and liquid fill technology of hard capsule. It has the following benefits It has developed the multi-phase released product using specific excipients such as macrogol glucerides or technologies such as micro-emulsions. Now formulation of fixed combination products has become easy.

Page 6 of 8 In the gastrointestinal tract, site-specific degradation can be avoided. It meets marketing needs. Filling of capsules into larger liquid fill capsule has become able by Duocap system. By this system either or both capsules may be coated. Technological application for probiotics Probiotics can be defined as live microbial food supplements which have health benefits and improve the microbial balance of the intestine. The product quality for probiotics can be improved by using an HPMC capsule format. The shells of these capsule contain less than half of the moisture of gelatin capsule. For freeze dried probiotics HPMC is a better choice because it is very resistant to dehydration and embrittlement. Anti-abuse and Anti-counterfeiting Anti-abuse and anti-counterfeiting are big consideration for product development since abuse affects personal safety and product counterfeiting affects both user safety and commercial integrity. Anti-abuse design can minimize abasement by two major ways If we make the mechanics of manipulating dosage form sufficiently complex, potential abuser will avoid the product and thus there will be minimization of abasement. The acute hazard can be minimize which is generated by intentional personal interference. For example, dose of opiate can be dumped from a high dose controlled release format.

Page 7 of 8 Conclusion Capsule dosage form is most acceptable dosage form to consumers because of its a wide variety route of administration and better bioavailability. Patient compliance is more in capsule dosage form than others. As because now more and more developments are coming so devoid of some disadvantages capsule dosage form is better.

Page 8 of 8 Reference Aulton, M. (ed) 2002, Pharmaceutics, The Science of Dosage Form Design, Soft Gelatin Capsules, Churchill Livingstone, 464-465 Banker, G. (ed) 2002, Modern Pharmaceutics, Hard and Soft ShellCapsules, Marcel Dekker, INC., 335-337 Lachman L. (ed) 1987, The Theory and Practice of Industrial Pharmacy, Capsules, Varghese Publishing House, 389-392 (2007), Advances in capsule technology for pharmaceuticals and nutraceuticals Available at>...>November 1, 2007 (accessed on 10th October) Vinesia (2010), Formulation; How to manufacture and produce pharmaceutical dosage form Available at 14/capsule-solid-dosage-form html (accessed on 5th October 2011) Vinesia (2010), Some of the problems encountered in the manufacture of drug Available at (accessed on 5th October 2011) .