CAPSULE Manufacturing

Purpose:

To manufacture of quality-efficient product for efficient healthcare service.

Capsule – Capsule is a solid dosage form in which the drug is enclosed in either a hard or soft soluble gelatin shell.

Capsule size – 8 type of size are available

000(Largest), 00, 0, 1, 2, 3, 4, 5(Smallest)

For 500mg – 00 sizes is needed

For 250 – 1 or 0 size is needed

Shape of soft gelatin capsule – Oval shape / Oblong / Round / tube / suppository – special shape

Introduction:

Capsule is a solid dosage of medicament in which the drug (s) is enclosed in a practically tasteless, hard soluble container or shell made up of a suitable form of gelatin. Hard capsules are used for filling the solid substances. Capsules are increasing their popularity day by day. Hard capsules come second to tablets in importance as solid unit dosage forms and it involves fewer inventories and equipment as well as acceptance by consumer.

Process Description: The principle steps of the hard capsule production are as follows:

                                        

                                     Granulation> Encapsulation> Blistering

Here discussed the most critical steps of capsule production that impact the quality of the product.

Capsule Filling/Encapsulation:

• Hard Gelatin Capsule

1. Size
2. Weight

• Machine
1. Hand Filling Machine
2. Semi-automatic machine
3. Automatic machine

The main operation includes:

a) Separation of bodies and caps

b) Filling of the bodies with the measured quantity of material uniformly by punching & vibration

c) Replacement of caps and then

d) Closing & ejection of the filled capsules

Formulation of capsules:

Capsules usually consist of active ingredient mixed with a number inert substances known as excipients. These excipients are added to give the qualities of good capsules. Although these excipients are termed as inert they have a great influence on stability, bioavailability and process by which the dosage forms prepared. According to the functions, which these additives play in the preparation of capsules, may be classified as follows:

• Active ingredient
• Diluents/filler/Additives
• Lubricates

Production Technology:

For production of capsules the initial step is to obtain a powder mixture/ granules as the active ingredients cannot be filled some times directly because of small volume, poor flow as well as sticky property. Like tablet powder mix for capsule also requires filler/diluents, lubricants, glidants, Lactose, starch, microcrystalline cellulose, calcium carbonate are the common filler/diluents. Metallic stearates, talc, starch are useful lubricants as well glidants. To prepare powder mixture care should be taken to have a homogeneous mixture. Remixing must not occur during mixing and filling operation. Sieving is some times required before mixing to reduce the loosely held agglomerates and also separate the large particles, which may cause weight variation. For flappy powder, densification as well as grading is necessary for appropriate dose level. At the present day compacted materials are available. Due emphasis shall be given for moisture content and content uniformity of powder mix/granules before filling into capsules.

For optimum performance during the filling operation, a temperature between 21-25 ⁰C

And Relative Humidity between 45% - 55% recommended in the filling area. In order to maintain the moisture content of the capsules in the required range, capsule can be used outside these conditions provided the minimum stock level is stored in the filling area. As a precaution against heat generation of some filling machines during operation.

Common Faults During Encapsulation:

1. Denting in body
2. Pin hole
3. 2 caps
4. Half capsule
5. Body to long
6. Crack capsule
7. Twisting in the cap
8. Black spot/greasy
9. Bad closure
10. Uncut
11. Ink spot
12. Chipped
13. Wrinkle