A solid dosage form in which a drug is enclosed in a hard or soft shell is a(n)

Capsules are a solid dosage form in which the drugs and/or excipients are enclosed in a soft or hard soluble shell. Generally, drugs in capsules are powders or granules that are irritating to the esophagus and gastric mucosa that are easily volatile, easily decomposed by saliva in the mouth, easily inhaled into the trachea or have bad taste. These medicines are packed into capsules, which not only protect the medicine from being destroyed, but also protect the digestive organs and respiratory tract. Removing the capsule shell may cause drug loss, drug waste and reduced efficacy. In addition, some drugs need to be dissolved and absorbed in the intestine, and the capsule can protect the drugs from being damaged by gastric acid.

Capsule shell is usually made of gelatin or other suitable polymeric materials. According to the composition of capsule shell, capsule can be divided into hard capsules or soft capsules. In addition, capsules come in standard sizes. These sizes range from 000 to 5, which have volumes from 1.36 to 0.13 mL. The size of the 000 capsule is the highest, and 5 capsule is the smallest.

The team of CD Formulation is leading experts in all aspects of pharmaceutical formulation development and dosage form optimization, we can accord the characteristics of the API and the development goals of the customers to design the capsules. CD Formulationcan provide you with one-stop services to meet your needs of capsules.

Advantage of Capsules

• Masking unpleasant odour and taste of the drugs
• Smooth when moist and can be easily swallowed
• Economical
• Easy to handle and carry
• Release the drug when desired in gastro-intestinal tract
• Attractive in appearance

Disadvantage of Capsules

• The hygroscopic drugs cannot be filled in capsules.They absorb water present in the capsule shell and hence make it very brittle, which ultimately breaks into pieces.
• The concentrated preparations which need previous dilution are unsuitable for capsules because it may lead to irritation in stomach if administered as such.

The Process of Developing Ointments Capsules

For capsules, the formulation requires the formation of a uniform plug of uniform weight. Relative simplicity of capsule preparation that can speed up the development process, especially for drugs with large dose and difficult to compress.

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If you have a requirement about capsules services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

1. Pharmaceutical Dosage Forms: Capsules[M]. CRC Press, 2017.
2. Gullapalli R P. Soft Gelatin Capsules (softgels)[J]. Journal of Pharmaceutical Sciences, 2010, 99(10): 4107-4148.
3. Hoag S W. Capsules Dosage Form: Formulation and Manufacturing Considerations[M]//Developing Solid Oral Dosage Forms. Academic Press, 2017: 723-747.
4. Fung K Y, Ng K M. Product-Centered Processing: Pharmaceutical Tablets and Capsules[J]. AIChE Journal, 2003, 49(5): 1193-1215.

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Learn about the capsule dosage forms-Types of capsules as Hard Gelatin Capsules, Soft Gelatin Capsules, Modified Release Capsules and Enteric Capsules.

Capsules are solid pharmaceutical dosage forms in which the drug or a mixture of drugs is enclosed in a Gelatin Shell or any other suitable material to form various shapes. Capsules generally contain a single dose of active ingredients and are taken orally.

Excipients such as opaque fillers, antimicrobial preservatives, sweetening agents, permitted flavoring agents and one or more coloring agents may be added. Capsules may be printed on the outer surface.

Capsules may contain medications in solid, paste or liquid forms. The API filled in the capsules may contain excipients as solvents or fillers but the shell should not be attacked by the content thereby releasing the contents of the capsule.

The contents of capsules other than Modified-release (Sustained-release) do not contain any added coloring agent.

There are following types capsules:

3.  Modified Release Capsules

1. Hard Gelatin Capsules:

Hard gelatin capsules contain the active ingredients in the form solids. When two drugs of different properties are added in a capsule, one of them should be in the form of the tablet, pellet or small capsule and then enclosed in the large capsule.

Hard gelatin capsules are manufactured by dipping capsule shell shaped pins into liquid gelatin solutions, after that gelatin films on the pins are dried, trimmed, and then removed from the pins. Body and cap pieces are supplied unlocked.

2. Soft Gelatin Capsules:

Soft gelatin capsules made from gelatin (sometimes called softgel) are somewhat thicker than that of hard gelatin capsules and may be plasticized by adding the sorbitol or glycerin. The ratio of plasticizer depends upon the environmental conditions as well as the nature of the contents filled into the soft gelatin capsule.

Like hard gelatin shells, the composition may include approved dyes and pigments and preservatives. Flavors may be added and up to 5% sucrose may be included for its sweetness and to produce a chewable shell. Soft gelatin capsule shell generally contains 6% to 13% of water.

Soft gelatin capsules are generally filled during their formation and sealed with machines.

Soft gelatin capsules generally contain liquid or solid drugs dissolved in suitable liquids to form a paste. In some cases, granules and powders may be filled with the soft gelatin capsules.

3. Modified Release Capsules:

Modified-release capsules are hard or soft gelatin capsules in which the contents or the shell, or both are prepared by a special process to modify the rate of releasing the active ingredients of the capsule.

4. Enteric Capsules:

Enteric Capsules are hard or soft gelatin capsules those are resisted against the gastric fluid but dissolves in the intestinal fluid to release its contents.

During manufacturing, packaging, storage and distribution of capsules, their microbial quality should be maintained as per their acceptance criteria because of the possibilities of microbial growth in gelatin.