Solid Dosage Forms (Capsules) Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics Faculty of Pharmacy Omer Al-Mukhtar University Tobruk, Libya. E-Mail: nanjwadebk@gmail.com 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya. Content Definition Advantages and disadvantages Types of capsules Methods of filling the hard gelatin capsules Method of filling of soft gelatin capsules Different between hard gelatin and soft gelatin capsules Evaluation of capules Special Applications of Capsules Packing and Storage of Capsules 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya. Definition Capsules are a solid dosage form in which the drug substance is enclosed in a water soluble shell or an envelope. A capsule shell is made from gelatin. The capsules are available both as hard capsule and soft capsule. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Advantages of capsules The drugs having unpleasant odour and taste can be administered by enclosing them in a tasteless shell. They are smooth, become very slippery when moist and can be easily swallowed. They are economical. They are easy to handle and carry. The capsules release the medicament as and when desired in gastro-intestinal tract. Capsules are made from gelatin and hence they are therapeutically inert. They are attractive in appearance. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Disadvantages of capsules The hygroscopic drugs cannot be filled in capsules. They absorb water present in the capsule shell and hence make it very brittle, which ultimately breaks into pieces. The concentrated preparations which need previous dilution are unsuitable for capsules because it may lead to irritation in stomach if administered as such. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya. Types of Capsules Capsules are available in two types: Hard gelatin capsules Soft gelatin capsules 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya. 1. Hard Gelatin Capsules These are used for administration of solid medicaments. The capsule shell is prepared from gelatin, color and titanium dioxide to make it opaque. It consists of two parts i.e. body and cap. The powdered material is filled into the cylindrical body of the capsule and then the cap is placed over it. The empty capsules are available in various sizes. They are numbered according to the capacity of the capsules. The number starts from 000 and goes up to 5. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Approximate capacity in mg 1. Hard Gelatin Capsules Capsule number Approximate capacity in mg 000 950 00 650 450 1 300 2 250 3 200 4 150 5 100 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya. 2. Soft Gelatin Capsules These are used for administration of liquid medicaments. Soft gelatin capsules are available in round, oval and tube like shapes. They are made from gelatin. The gelatin is plasticized by the addition of glycerin and sorbitol etc. The soft gelatin shell may contain a preservative to prevent the growth of fungi. They are used to enclose liquid medicaments-oils, suspensions, food concentrates and ophthalmic products. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Excipients used in the filling of capsules While filling solid medicaments in a powder form into the body of hard gelatin capsule, the following additives, too are included in the formulation: Diluents Absorbents Glidants Antidusting compounds 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Methods of filling the hard gelatin capsules The capsules can be filled either by hand or by a semi-automatic device or by an automatic filling machine. Capsule filling machine (Hand operated) It consists of:- A bed having 200-300 holes A loading tray having 200-300 holes A powder tray A pin plate having 200-300 pins A sealing plate having a rubber top A lever A cam handle 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Capsule filling machine (Hand operated) 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Method of filling of soft gelatin capsules Soft gelatin capsules are generally filled mechanically. The manufacturing of the capsule shell and the filling of the medicament take place simultaneously. Nowadays, a rotary machine is used for this purpose. In a rotary die machine, the soft gelatin capsules are prepared and then filled immediately with the liquid medicaments. The machine consists of two hoppers. Liquid gelatin mixture is placed in one hopper and the liquid medicament in the other hopper. There are two rotating dies which rotate in opposite directions. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya. Rotary machine 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Difference between Hard Gelatin and Soft Gelatin Capsules Sl. No. Hard gelatin capsules Soft gelatin capsules 01 The hard gelatin capsule shell consists of two parts: (a) Body; (b) Cap. The soft gelatin capsule shell becomes a single unit after sealing the two halves of the capsules. 02 They are cylindrical in shape. They are available in round, oval and tube like shapes. 03 The contents of a hard gelatin capsule usually consists of the medicaments or mixture of medicaments in the form of powder, beads or granules. The contents of soft gelatin capsules usually consists of liquids or solids dissolved or dispersed in suitable excipients to give a paste-like consistency. 04 These are prepared from gelatin, titanium dioxide, coloring agent and plasticizer. These are prepared from gelatin, plasticizer (Glycerin or Sorbitol) and a preservative. 05 Capsules are sealed after they are filled to ensure that the medicaments may not come out of the capsule due to rough handling. Filling and sealing of soft gelatin capsules are done in a combined operation on machines. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Evaluation of Capsules The following tests should be carried out for evaluation of the capsules: Uniformity of weight Content of the active ingredients in the capsules Disintegration test Dissolution test 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Special Applications of Capsules Enteric-coated capsules Sustained release capsules Rectal capsules Capsules containing ophthalmic ointments 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Packing and Storage of Capsules Capsules should be packed in well-closed glass or plastic containers and stored at a temperature not exceeding 30 0C. They should comply with such additional storage requirements as are specified in the individual monographs given in the pharmacopoeia of India. Capsules can be individually protected by enclosing them in a strip or blister packs. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

Packing and Storage of Capsules In strip packing, the capsule is hermetically sealed within the strips of an aluminium foil and/or plastic film. The contents are removed from the strip packs by tearing or cutting to separate the capsules. In case of blister packs, a press on the blister forces the capsule through the backing strip. Generally, capsules have a longer shelf life in unopened glass bottles than in strip-packs but this is reversed, once a bottle has been opened. 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

THANK YOU e-mail nanjwadebk@gmail.com 2014/05/31 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.