Capsules are solid dosage forms mainly for oral use prepared by filling drug powders together with suitable excipients into empty shells.the capsule shell is able to mask undesirable taste or odor, it also protect the capsule from exterior moisture.
Soft capsules:An outer solid shell (softgel or soft gelatin capsule) encloses a liquid or semi-solid interior (inner fill). Both the inside fill and the outside shell may include active ingredients. Similar to capsules, they are an oral dose form for medication. Gelatin, water, an opacifier (such as glycerin or sorbitol), and a plasticizer are all ingredients in softgel shells.
For the peroral administration of unappealing and/or greasy liquids, soft gelatin capsules offer a dose form that is patient-friendly.
2. Soft gelatin capsule dosage forms, which offer a neat look and convenient ingestion, can readily be used to administer solutions or suspensions with a disagreeable odor or taste.
3. Making the right vehicle choice could encourage the quick release of the medicine and dispersion of the capsule’s contents.
4. When making soft gelatin capsules, greater levels of repeatability are attained.
5. Drugs that are lipid-soluble at low doses may benefit especially from soft gelatin capsules
6. For the encapsulation of liquid, water-insoluble pharmaceuticals, it may also be a better option than a tablet dosage form.
7. The capsules may have an enteric coating, a delayed or sustained release (SR), or an immediate release formulation (IR).
-The need for specialized manufacturing equipment
-Stability issues with extremely water-soluble and hydrolyzable chemicals.
-There aren’t many excipients or carriers that work with gelatin.
The shell of soft capsules possess both plasticity and elasticity,which serve as the basis for the preparation of capsules. The shell is often comprised of gelatin of gelatin,plastisizers and water . The function of the plasticizers is to modulate the plasticity and elasticity, but more importantly to prevent the shell from loosing water during storage, which might result in hardening of the capsules shell and prolonged disintegration. Colorants,antiseptics and light screening agents can be added as needed.
The content of soft capsules can be a solution,suspension,solid or semi solid. Since gelatin is the main component in the capsule shell,there are certain requirements for the content should not exceed 5%. Volatile small molecules such as alcohols,acids,ketones and esters should be avoided because they are able to soften or even dissolve the shell. Aldehydes should be avoided as well,because they may react with gelatin. The pH of the liquid content should be in the range of 2.5-7.5, other wise gelatin tends to hydrolyse the nature.
soft gelatin capsules are manufactured by machines equiped with double layer dropping nozzles. the wall gel fluid and drug fluid simultaneously flow out from interior to exterior layer of the double layer nozzle. The wall gel engulfs the drug fluids and the combined material falls into an immiscible cooling fluids,where cooling continues until the wall gel solidifies to form soft capsules.
in this method a wall gel is first prepared into a gel belt of uniform thickness then the drug fluid is placed between two gel belts and compressed into a mold form of soft gelatin capsule.
A hard gelatin capsule is a particular kind of capsule that’s typically used to hold medicine that comes in the shape of dry powder . Tablets and powder-filled hard gelatin capsules are examples of oral drugs. Typically, powders, granules are placed inside hard gelatin capsules.
– It is frequently believed that hard gelatin capsules have higher bioavailability than tablets.
-Hard gelatin capsules enable a level of formulation flexibility not possible with tablets.
-It is now possible to fill many capsules with a variety of systems, including beads, granules, tiny tablets, powders, and even semisolids.
-Bead-type modified-release products can be loaded into capsules since they are packed without compression, which could cause the particles to burst.
-Hard gelatin capsules are frequently utilized in early drug research and are perfect for clinical trials.
-The fact that there are few shell suppliers is possibly a drawback from the manufacturer’s perspective.
-It’s possible for hard gelatin capsules and tablets to get stuck in the esophagus, where the localized high concentration of some medications may be harmful.
-Generally speaking, hard gelatin capsules shouldn’t be used to administer highly soluble salts (such as bromides, chlorides, and iodides).
-Products made of hard gelatin capsules are typically more expensive to make than tablets.
-Although this difference has closed recently with the introduction of high-speed automatic filling machines, filling equipment is still slower than tableting equipment.
The preparation of hard capsules includes identification of appropriate shell,preparation of filling content,filling and encapsulating. Empty shells can be chased from appropriate manufacturers. Empty shells are comprised of gelatin,plastisizers and water,as well as accessory components like colorants,antiseptics and light screening agents.
Gelatin capsules are prone to hardening upon dehydration,softening upon hydration and react with aldehydes.Therefore,they require more stringent controls for storage temperature,humidity and package materials. In order to overcome this problem,shell made from botanical polysaccharides and dietary fibers such as starch capsules, methyl cellulose capsules,are employed as a substitute for gelatin capsules.Furthermore,botanical capsules are more stable with less inter-individual variations,highly flexible and able to withstand higher temperatures.
-Soft gelatin capsules can perhaps function more quickly than other types of capsules because they dissolve easily in the gastric juices of the stomach.
A soft gelatin capsule is used to contain medication that is in the form of a liquid or powder because it dissolves more rapidly than a hard gelatin capsule.
-When compared to soft gelatin capsules, which are sealed up one-piece capsules that cannot be detached, hard gelatin capsules feature two distinct parts: a body and a cap.
-Soft gelatin capsules normally hold liquids and semisolids while hard gelatin capsules frequently contain dry powders, plugs that have been slightly compressed, granules, or tablets.
-While soft gelatin capsules come in round, oval, and tubular shapes, hard gelatin capsules are cylindrical.
-A hard gelatin capsule contains less plasticizer than a soft gelatin capsule.
-While the production of hard shell capsules requires two separate machines—one for the shells and another for the filling—the production of soft gelatin capsules only requires one equipment for the feeding and sealing steps.
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