AN OVERVIEW OF PRODUCTION IN CAPSULE DEPARTMENT 

Capsules

PROJECT REPORT ON CAPSULE DEPARTMENT, Capsules are solid dosage forms in which one or more medicinal/inert substances are enclosed within a water-soluble small shell or container generally prepared from a suitable form of gelatin.

The capsule is the most versatile of all dosage forms. In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:

 Hard-shelled capsules, which are typically made using gelatin and contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronisation. These are made in two halves: a lower-diameter “body” that is filled and then sealed using a higher-diameter “cap”.

 Soft-shelled capsules are primarily used for oils and for active ingredients that are dissolved or suspended in oil.

Both of these classes of capsules are made from aqueous solutions of gelling agents like:

 Animal protein, mainly gelatin;

 Plant polysaccharides or their derivatives like carrageenans and modified forms of starch and cellulose.

Other ingredients can be added to the gelling agent solution like plasticizers such as glycerin or sorbitol to decrease the capsule’s hardness, coloring agents, preservatives, disintegrants, lubricants and surface treatment.

Since their inception, capsules have been viewed by consumers as the most efficient method of taking medication. For this reason, producers of drugs such as OTC analgesics wanting to emphasize the strength of their product developed the “caplet” or “capsule-shaped tablet” in order to tie this positive association to more efficiently-produced tablet pills. After the 1982 Tylenol tampering murders, capsules experienced a minor fall in popularity as tablets were seen as more resistant to tampering.

Advantages of Capsules:

1. Better bioavailability is expected than a tablet because they release drugs rapidly & is not compacted.

2. They are much more flexible to formulate compared to tablet – they are easily compounded, there is no need to form a compact resistant to handling, unique mix fills is possible, and they have important roles in drug development & clinical trial phases (as the drug can be administered W/O any additives)

3. They provide good barriers to atmospheric 02.

4. They are elegant, hence more patient-compliant.

5. They are portable dosage forms.

6. They provide a smooth, slippery, easily swallowed & tasteless shell for drugs.

7. They can make any drug administration a tasteless & odorless dosage form.

8. They can be economically produced in large quantities, & in a wide range of colors.

Disadvantages of Capsules:

1. Capsules may be difficult to formulate with very bulky materials as size is limited.

2. Capsule-filling equipment is slower than tableting equipment.

3. They are more costly than tablets; however, this should be judged on a case-by-case basis, tablet may be more expensive also.

4. There is concern over maintaining proper shell moisture constant. Usually, the shell moisture content is 13-15% W/W & should be stored (unprotected) at a relative humidity of 45-65%. If it is too dry; it will become brittle/easily fractured. If too damp, they become soft and sticky. Also, highly hygroscopic drugs/efflorescent/deliquescent material may be quite difficult to formulate, as they may be softer/make the shell brittle respectively.

5. Cross-linking of gelatin may occur by reacting c the contents leading to a change in the flexibility of the shell & its reduced solubility.

6. Highly soluble salts (KCl, KBr, NH4Cl) should not be administered in capsules, as their rapid release cause gastric irritation due to localized high concentration.

7. Suppliers of the shell may be limited.

8. HGC (& also tablets) may get lodged in the esophagus & may have consequential problems.

Types of capsules:

 Hard capsules;

 Soft capsules;

 Modified-release capsules

Administration – Usually orally for both HGC & SGC. HGC is formulated at least 10 times more than SGC.

Some SGC may be used for rectal/vaginal insertions for local action. Some soft caps are available for ophthalmic administration after cutting a part of the producing shell of these special-shaped capsules.

PROJECT REPORT ON CAPSULE DEPARTMENT

Also, Visit: Training Report for pharma students