Gelatin is derived from naturally occurring collagen found in connective tissue. Gelatin is a pure protein, is easily digestible and free from side effects. Gelatin capsules are not vegan nor vegetarian. Vegetarian capsules or vegan capsules, although a much smaller component of the global market, serve niche segments.
Capsules can be made from gelatin or from other hydrocolloids gelling agents. Gelatin, however, has been used for oral dosage forms for hundreds of years and is beloved and expected by consumers around the world. Like their hard capsule counterparts, softgels offer value to consumers and producers alike.
These advantages are due largely due to their main component, gelatin. Gelatin means "stiff" and is a colorless dry powder that has been used for centuries in a host of food and pharmaceutical uses. For consumers, gelatin dissolves in the human body at normal body temperature, making it the ideal ingredient in softgels. While protecting the precious actives inside the capsule against oxygen, light, moisture and dust, the gelatin of the softgels affords consumers easy swallowing.
Consumers also appreciate that the capsule size and color can help them to more easily identify the respective pharmaceutical drug or nutrient inside. There is no standard capsule size. Gelatin lends itself to a high degree of flexibility, allowing capsule producers to custom size, shape and color!
Reputable gelatin suppliers adhere to strict quality requirements and local and global regulations. Further, these same gelatin companies administer rigorous physical, chemical and microbiological testing before the gelatin is released to capsule producers. Just let us know if you still have any questions around the topic Capsules and Gelatine.
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Moisture content is especially useful in this regard. If the moisture content decreases, the capsule shell becomes brittle and it is more prone to breakage. On the other hand, a capsule shell deforms and becomes sticky in the presence of high moisture content. Again, on exposure to stress and aging, cross-linking of gelatin occurs and ultimately leads to reduced solubility of gelatin. Acetylation, use of masking agents e.
The manufacturers were directed to gather information regarding any ovine or bovine material and to ensure that these materials are not from bovine spongiform encephalopathy BSE -endemic countries.
In December 17, , the US-FDA recommended manufacturers not to use bovine-derived materials from cattle resided or originated from BSE countries and issued direction regarding the identification of origin of bovine-derived materials, to maintain traceable record of each lot of bovine-derived material and country of origination of the materials.
Skin-derived gelatin has less risk than bone-derived gelatin and specially bone of vertebral column and skull, where the chance of contamination is highest. Documentation of source and traceability of record is must. Gelatin processors should ensure that slaughterhouses that supply bovine bones for gelatin production remove heads, spines, and spinal cords as the first procedure following slaughter.
Raw materials should not be collected from cattle that show signs of neurological disease. BSE-free country BSE-related standards of the Office International des Epizooties is preferable, but can also be collected from non-BSE countries if the cattle come from BSE-free herds and if the slaughterhouse removes the heads, spines, and spinal cords directly after slaughter. Use of alkaline hydrolysis further reduces the risk of TSE. The raw materials can be further processed to make the risk even lower.
Use of plasticizers shares many problems such as phase separation and consequent migration of plasticizer to the surface of capsule. Oxygen permeability and loss of volatile fill components can be minimized by the use of nonglycerol plasticizers or substituting a portion of glycerol with higher polyol plasticizer and maintaining low shell moisture content; protecting the capsule against high humid conditions.
Gelatin capsules are being used worldwide for the past years with known safety and toxicity profile. Gelatin is easily available from hydrolysis of collagen whereas manufacturing of HPMC is a synthetic process. Raw materials for gelatin are readily available in the market which can fulfill the requirement of industries in India whereas raw materials for non-gelatin are quite less available and hence they are four times costlier than their gelatin counterpart.
Moreover, most of the vegetable capsule shell technologies are in patent period, contributing to the cost component of these capsule shells. Food habits vary from person to person and place to place. Religion is the vital source of such variation. Jainism people are vegetarian but they do not take some vegetarian foods such as potato, carrot, onion, and garlic which are grown below earth. All the different cultures have their own beliefs and habits.
Therefore, we must remember that medicine should not be treated as food articles and is independent of these thoughts or boundaries to save life of patients. We can see that both gelatin and nongelatin capsules are comparable in toxicity. However, lower moisture content, low hygroscopicity, physical stability, stability in different ranges of temperature and humidity are advantages that favor the use of nongelatin capsules.
But, to keep in mind is that gelatin is an age-old technology with proven safety record. Manufacturing easiness, easily available raw material, and low cost are advantages of gelatin capsules. Regarding the vegetarian versus nonvegetarian issue, defining vegetarian is a difficult issue, with special reference to variation among different religious beliefs present.
Many a times, manufacturing of drugs requires different reagents of animal origin. Again, different drug products are also of nonvegetarian origin, for example, hormonal products, heparin, insulin, antiserum, and human cell line-derived products. Involvement of all these complicated issues makes determination of vegetarian and nonvegetarian capsules complicated. Again, this will create chaos between patients and doctors regarding the prescription of vegetarian versus nonvegetarian capsules.
Scientific and manufacturing advantages can guide in this issue. On the ethical basis, representation says that gelatin-based capsules should be allowed to be marketed without any additional labeling.
The DTAB's decision is in line with the Supreme Court decision which stated that cosmetics and drugs cannot be treated at par with food articles, when it comes to labeling them with a brown or a green mark to distinguish the vegetarian and nonvegetarian ingredients and hence, we are with the decision of the Supreme Court. National Center for Biotechnology Information , U. Journal List Indian J Pharmacol v. Indian J Pharmacol. Author information Article notes Copyright and License information Disclaimer.
Address for correspondence: Dr. E-mail: moc. Received Feb 14; Accepted Aug Strachan I, Greener M. Medication related swallowing difficulties may be more common than we realise. Pharmacy in Practice, December 2. Consensus guideline on the medication management of adults with swallowing difficulties. In: Foord-Kelcey G, editor. Guidelines — summarising clinical guidelines for primary care. Wright D et al. Prescribing medicines for patients with Dysphagia.
A handbook for healthcare professionals. Medicines Management and Older People- a guide for healthcare professionals. Edited by R Greenwall. August
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