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Introduction to medical capsule production technology

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Introduction to medical capsule production technology

A capsule (from Latin capsula – case or shell) is a dosage form consisting of a medicinal product enclosed in a shell. In 1846, Frenchman Jules Leuby received a patent for a «method of making drug coatings». He was the first to produce two-part capsules, which he obtained by dipping metal pins fixed on a disk into a gelatin solution. The two parts were fitted together to form «a cylindrical box shaped like the cocoon of a silkworm.» In these capsules pharmacists could put already powders or their mixtures, made according to the doctor’s prescription. In its modern form, this method is used in the production of hard bivalve gelatin capsules. Capsules in their present form can be considered a relatively young dosage form. The impetus for the development of such a dosage form as capsules was the beginning of widespread use in medical practice of antibiotics characterized by an unpleasant bitter taste. Currently, capsulated drugs are gaining importance due to their distinct advantages over other dosage forms. The term «capsules» refers to two types of products of pharmaceutical production: special containers, containers prepared from starch or gelatin mass, for placing in them different doses of drugs, ready dosage forms – starch capsules or clouds, gelatin or polymer capsules and microcapsules filled with powdered, granular, paste or liquid drug substances. In the modern pharmaceutical market, gelatin capsules are traditionally used, so the following will focus on the production of such capsules. Depending on the content of plasticizers and on the technological principle, two types of capsules are distinguished: hard, with caps (Capsulae durae operculatae); soft, with a solid shell (Capsulae molles). The consistency of capsules depends on the ratio of the three main components: gelatin, glycerol and water. Glycerin can be partially replaced by other plasticizers such as sorbitol or sugar syrup.

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  • Información actualizada : 09 / 11 / 2024
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  • Fabricante : 1 año para Introduction to medical capsule production technology

Modelo: Production of capsules from gelatin

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Fewer excipients in the manufacture of capsules than, for example, in the manufacture of tablets. In addition, capsules require less machinery due to fewer production steps, fewer analytical techniques to be used in the required analyses, and fewer authorization procedures and documents than tablet production. In soft and hard capsules, drugs can be encapsulated in unaltered form without wet granulation, heat, and pressure as in tablet manufacturing. In addition, the number of factors affecting the processes of release and absorption of drugs from capsules is much smaller than for other dosage forms. A disadvantage of gelatin capsules is their high sensitivity to moisture, which requires compliance with certain conditions for their storage. Another disadvantage is the fact that gelatin is an excellent breeding ground for microorganisms. This disadvantage is prevented by adding preservatives to the mass: nipagin (0.4%), nipazole (0.4%), sorbic acid (0.1-0.2%) and others. Gelatin capsules may differ in capacity. At the same time hard capsules are produced worldwide in 8 standard sizes (Standart): from No. 5 (the smallest) to No. 000 (the largest). Some companies have mastered the production of an additional ninth size No. 0e1 (0 elongated, i.e. size 0 for elongated capsules). In addition to these, Supro capsules of five standard sizes from A to E have recently become widespread abroad.

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Especificaciones técnicas

Solid capsules are intended for dispensing loose powdery or granular substances. They have the shape of a cylinder with hemispherical ends and consist of two parts: a body and a cap; both parts must fit freely into each other without forming gaps. Hard capsules are filled after the molding process has been fully completed and they have acquired the appropriate elasticity and rigidity. Hard capsules have a two-part structure and can be manufactured in advance and filled with drug substances as needed. Soft capsules are designed for liquid or paste-like drug substances. Capsules have different shapes: spherical, ovoid, oblong or cylindrical with hemispherical ends. Soft capsules got their name due to the fact that in the process of their manufacture, the filler is placed in a still soft elastic shell. The capsules are then subjected to further manufacturing processes that may result in the original elasticity of the shell being partially or completely lost. Such capsules have a one-piece shell, which may be elastic or rigid. Sometimes the shell of soft capsules contains the active substance.Capsules are intended for oral, less often rectal, vaginal and other routes of administration. Depending on the localization of oral capsules are divided into sublingual, gastric-soluble and intestinal-soluble (resistant to the action of gastric juice, but easily destroyed in the environment of the small intestine). Modified-release capsules have special excipients in the contents or shell designed to change the rate or location of release of active ingredients. Intestinal soluble capsules are also classified as modified-release products, which must be stable in gastric juice and release the active ingredients in the intestine. They can be manufactured by coating hard or soft capsules with an acid-resistant shell or by filling capsules with granules or pellets coated with acid-resistant shells.

Información adicional

Currently, the dosage form in the form of gelatin capsules has become very popular with pharmaceutical manufacturers, consumers and physicians due to a number of advantages and positive characteristics. These include, among others:
High dosing accuracy of the drug substances placed in them. Modern equipment ensures high accuracy of filling capsules with filler (with a tolerance not exceeding ±3%) and minimal losses. High bioavailability. Studies have shown that capsules often disintegrate faster in the human body than tablets or dragees, and their liquid or unabsorbed solid contents are more quickly and easily absorbed. The pharmacological action of the drug substance is manifested in 4-5 min. High stability. Drug substances in capsules are protected from various unfavorable environmental factors – the effects of light, air, moisture, mechanical influences – due to the shell, which provides a sufficiently high tightness and isolation of components. Therefore, in the manufacture of capsules it is possible to avoid the need to use antioxidants or stabilizers or reduce their amount.
Corrective ability – unpleasant taste and odor of medicinal substances is eliminated, which is especially important in pediatrics. High aesthetics – achieved through the use of various dyes in obtaining capsule shells. Today, leading pharmaceutical companies use up to 1,000 different colors and shades for coloring capsule shells.
Possibility to set specific properties of drug substances – creation of intestine-soluble capsules, as well as urethard capsules (with prolonged drug release), which can be achieved by various technological methods.

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