Again, categorizing non-lifesaving drugs only as vegetarian or nonvegetarian is also absurd as there is no fixed criteria to categorize drugs as lifesaving or nonlifesaving, as depending on patient's condition, an ordinary drug may become lifesaving. Hence, vegetarian versus nonvegetarian distinction in case of drugs was rejected.
Being scientific at cases, there are differences in both the categories of capsule which cater the different properties of ingredients. While preparing gelatin shells, collagens of mammals are preferred compared to collagen of lower animals due to more stability of the former. The stability of gelatin is highest between pH 4 and 7.
Both hard and soft capsule shells can be prepared from gelatin. Plasticizers, especially nonvolatile plasticizers, are used in the manufacturing of soft shells.
These plasticizers reduce interaction between protein molecules and allow retention of moisture by gelatin. Glycerol and sorbitol are used commonly, but sorbitol is associated with blooming crystallization , when stored at low humid temperature.
Hence, glycerol is blended with sorbitol. Polyethylene glycols PEGs can also be used. The observations of Cole et al. Despite difference, there was no significant difference observed in terms of pharmacokinetic parameters such as C max and area under the curve. HPMC hard shells are less dependent on moisture content for integrity and thus cells are resistant to breakage even in dry conditions. Compared to gelatin, HPMC is a nonionic polymer and it has less compatibility changes with most encapsulated material and aldehyde impurities present therein.
One limitation of HPMC capsule shell is higher oxygen permeability due to looseness in its structure, which warrants caution for oxygen sensitive compounds. Inclusion of an anti-oxidant in the fill formulation or packaging the capsule into an oxygen-resistant configuration such as blister package with aluminum foil may prevent this oxidative damage.
Improved HPMC versions are available which do not require a secondary gelling agent e. HPMC dissolution and disintegration time is usually longer than that of hard gelatin capsules. Gelling agents may interact with cations in dissociating medium such as potassium and calcium ions. However, dissolution of improved newer versions of HPMC capsules is independent of pH and the ionic nature of dissociating medium.
Ideal properties of soft capsules are that they should be strong, more elastic, and fusible. These properties are ideally seen in gelatin which lack in nongelatin polymer capsules.
In experimental studies using amoxicillin as a model drug, gastrointestinal transit time and plasma amoxicillin concentration were found to be comparable between gelatin and starch-based capsules.
Starch capsules have the advantage of superior finishing and can be easily coated for preparation of modified release forms. Coating is easy in case of starch capsule owing to its smooth seal and bulk density.
Other options are starch polyvinyl alcohol PVA -based capsules. Compared to soft gelatin capsules, water migration is less in starch-PVA-based preparations and hence, subsequent less drug crystallization. Another advantage is the surface of starch-PVA capsules is more rough and hence more resistant to mechanical deformation and more amenable to coating process.
Gelatin contains all essential elements with the exception of tryptophan and cysteine. Tryptophan is essential for bacterial growth, and lack of tryptophan prevents microbial growth. At ideal packaging and storage conditions, both gelatin and nongelatin capsules are comparable in terms of microbial growth.
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. Getting a pill stuck in your throat can be a scary experience, but it's usually not an emergency.
Pills often get stuck in your throat when there's…. Gummy vitamins are increasingly popular. This article tells you whether they are good or bad for your health. These medication reminders are all better than your average pillbox. From apps to handheld timers, they make it easy to manage your medication…. Drug-induced hypersensitivity syndrome DIHS is a rare, severe reaction to a medication. Learn about causes and risk factors, plus what to do if it…. Soap and water are the best choices to help prevent the spread of germs.
But in a pinch, alcohol-based hand sanitizer is a good alternative if…. Health Conditions Discover Plan Connect. Tablets vs. What is a tablet? What is a capsule? Pros and cons of tablets. Pros and cons of capsules.
Is it safe to crush tablets or open capsules? What can make it easier to swallow a tablet or capsule? Is one type safer than the other? The bottom line. Read this next. Medically reviewed by Debra Sullivan, Ph. Medically reviewed by Alan Carter, Pharm.
Pill Stuck in Your Throat? Medically reviewed by Elaine K. Luo, M. Do Gummy Vitamins Work? The Benefits and Downsides. For the patients, it meant they no longer had to put up with bitter tasting medicines. By the end of the 19th century, America had become the world leaders in the development of gelatin capsules.
Between , American pharmaceutical company Eli Lilly built their first ever capsule manufacturing plant for the production of the newly developed 2-piece, self-locking hard capsule. Within twenty years they developed the first automatic method for manufacturing hard capsules which revolutionized the industry.
In , Robert P. Scherer revolutionized the production of soft gelatin capsules softgels by developing an automatic, continuous filling machine that made mass production possible. Owing to its reliability and safety, gelatin has been the shell excipient of choice for pharmaceutical manufacturers.
However, because gelatin is not the best option for vegetarians, manufacturers wanted to come up with an alternative ingredient. So in the first generation of vegetarian semi-synthetic hydroxypropyl methylcellulose HPMC hard capsules came on the market, shortly followed by vegetarian soft capsules made from semi-synthetic modified starch.
In recent years, consumers have become more aware of the origin, sustainability and health aspects of the products they buy. This is partly fueled by the tightening of labelling legislation and transparency on food products e. Food additives also known as E-numbers are substances not normally consumed as a food in itself and not normally a characteristic ingredient of food.
Many gelatin alternatives carry an E-number e. These two products are relatively new on the market, are plant derived, and processed using synthetic chemicals. The HPMC manufacturing process, for example, involves a reaction of purified cellulose with reagents such as methyl chloride and propylene oxide, the latter being classified - by the US Environmental Protection Agency - as a probable human carcinogen.
The use of gelatin as a food ingredient can be traced back to the Middle Ages, when it was used as an ingredient for jellied food products. Nowadays, it is part of our everyday lives and an ingredient of choice for many consumers around the world. Gelatin is derived from natural resources and obtained through partial hydrolysis of collagen contained in animal skins and bones.
As a pure and high quality protein coming from by-products of the meat industry, Gelatin helps to minimize wastage. And no chemical modification takes place during the entire manufacturing process. Optimizing the benefits of gelatin makes sense as it helps to reduce wastage. As traceability is vital in food production, all raw materials undergo strict testing and control to ensure maximum quality, safety and traceability.
One can ask: what is truly natural? What are we looking for when we ask for a sustainable product? Is it the origin, or does it include the process and potential chemical modification as well? Capsules based on plant derived products answer the increasing demand for vegetarian based products, but seem to leave the natural demand unanswered.
On the other hand, gelatin capsules answer to the natural choice, but can only leave the vegetarian trend unanswered. Recently in India some vegetarian lobby groups were pushing the Indian government to make HPMC capsules the standard dosage form for medication. The Indian government commissioned a study to look at the viability of such a move.
The study concluded that gelatin capsules are more efficient, present minimal manufacturing complications and are generally the safest option for dosing medication.
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