PRODUCTION OF GELATIN CAPSULES FOR MEDICINES

Filling technologies for hard gelatin capsules

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Over the past few years, capsule filling technology has undergone significant changes in the pharmaceutical industry. The basic idea of capsule filling has expanded from filling with solid forms to filling with liquid forms. Until recently, soft gelatin capsules were the only alternative for encapsulating difficult-to-dissolve dosage forms. Today, new technologies have been developed for filling solid gelatin capsules with liquid medicinal substances and sealing them as an alternative replacement for soft gelatin capsules. This simplifies the process of filling capsules and helps to avoid many problems associated with filling soft gelatin capsules. The fundamental differences between the filling of hard and soft gelatin capsules are as follows. Moisture content. In solid gelatin capsules, the moisture content can reach up to 50%. Soft gelatin capsules…

Ingredients of gelatin capsules

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Soft gelatin capsules are a dosed soft dosage form, which consists of a shell and a drug enclosed in it. Capsules can have different shapes (round, oval, oblong, etc.), different size, color and consistency of the filler. To obtain capsule shells, various film-forming high-molecular substances are used, which are capable of forming elastic films and are characterized by a certain mechanical strength. Gelatin is the most widely used by the modern pharmaceutical industry as a forming material, so most capsules produced in the industry* are gelatin capsules.

Preparation and filling of gelatin capsules

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The calculated amount of purified water is poured into the container, which is heated to a temperature of + 65 ° C in a gelatin mass preparation apparatus, and a stirrer is turned on. Then glycerin is poured with nipagin and gelatin is filled in. The gelatin mass is mixed for 1.5 hours until the gelatin is completely dissolved, then, with the agitator turned off, it settles for 0.5—1.5 hours. After that, the gelatin mass is filtered through a sieve and its viscosity is measured using a viscometer. If the viscosity indicators do not correspond to the norm, the ratio of water and gelatin is recalculated. The filler solution is prepared according to the technological instructions. The prepared gelatin mass and filler in the required...

Orientation, closing unloading, capsule cleaning

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There are empty capsules in the capsule bin. The capsules move down into two magazines, are aligned by the sorting unit and lowered into the corresponding cells. At the first stage of this operation, the first (internal) one is loaded a row of capsules, on the second one — the second (external) one is loaded a number of capsules. After the capsule magazine there is a narrow calibration hole. Only geometrically correct capsules can pass through this hole. In case of irregular shaped capsules that are unable to pass through the calibration hole, the cells are blocked, recognized by the scanner and excluded from the further filling process.

Production of hard gelatin capsules

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As noted above, encapsulated dosage forms are becoming increasingly important due to their obvious advantages over other dosage forms. This section will consider the technology of production of solid gelatin capsules, which are most widely used in the modern pharmaceutical industry, as well as the equipment on which their manufacture is carried out. Characteristics of the main and auxiliary substances included in the composition of solid gelatin capsules. To obtain capsule shells, film-forming high-molecular substances capable of forming elastic films characterized by a certain mechanical strength are used. Such materials include casein, zein, cellulose esters and esters, fats and wax-like substances, as well as some synthetic polymers (for example, a copolymer of methacrylamide and methacrylic acid, etc.). However, these substances have not found wide practical...

Soft gelatin capsules Basics of technology

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Soft gelatin capsules can also vary in capacity, although there is no clear standardization, unlike hard capsules. Suture soft capsules can hold up to 7.5 ml. The capacity of the rolls of the machine, with which the capsules are formed, filled and sealed, is measured in units called minim. At the same time, 1 minim is equal to an average of 0.062 ml, and the most commonly used roll cell sizes range from 2 to 80 minim. Larger capsules (up to 120 minim) have found application in the perfume industry.

Methods of industrial production of gelatin capsules

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There are three main methods of industrial production of gelatin capsules: immersion method, rotary matrix and drip. It should be noted that for the production of solid capsules, the dipping method has found wide application in industry, being essentially the only one. However, to obtain soft gelatin capsules (with drip sealing), the method is currently used only in laboratory conditions, as it is low-productivity and time-consuming. The stamping method, or rotary matrix, is used for the production of soft gelatin capsules and is the most rational for their production in industrial production. The principle of the method is to first obtain a gelatin tape, from which capsules are stamped on the rolls immediately after they are filled and sealed.

Filling gelatin capsules with powders and granules

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The reproduction and accuracy of dosing depends on the characteristics of the filler, the filling method and the type of filling machine. Active substances for filling into solid gelatin capsules must meet the following requirements: the contents must be released from the capsule, providing high bioavailability; when using automatic filling machines, active substances must have certain physico-chemical and technological properties, such as: certain particle size and shape; the same particle size; mixing homogeneity; flowability (fluidity); moisture content; ability to form compactly under pressure. To fill solid gelatin capsules, machines of various companies are used, differing in performance, dosing accuracy and the structure of the dispenser.

Introduction to medical capsule production technology

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Capsule (from Lat. capsula — a case or shell) is a metered dosage form consisting of a drug enclosed in a shell. In 1846, Frenchman Jules Leuby received a patent for a "method of manufacturing medicinal coatings". He was the first to start making two-piece capsules, which he received by lowering metal pins fixed on a disk into a gelatin solution. The two parts were adjusted to each other and formed a "cylindrical box in the shape of a silkworm cocoon." In these capsules, pharmacists could already put powders or mixtures thereof, made according to a doctor's prescription. In its modern form, this method is used in the production of solid bivalve gelatin capsules. Capsules in their modern form can be considered a relatively young...