Capsules

[blank_start]Hard Gelatin[blank_end] Capsules: • Drug • Powder or granulation [blank_start]Soft Elastic[blank_end] Capsules: • Liquid • Semi-solid mass

Shells are usually formed from [blank_start]gelatin[blank_end] but may also be made from [blank_start]starch[blank_end] or other substances. - Hard-shell capsule sizes range from No. [blank_start]5[blank_end] (smallest) to No. [blank_start]000[blank_end] (largest except for veterinary sizes) - Size No. [blank_start]00[blank_end] is generally the largest size acceptable to patients.

• Powder formulations often require adding [blank_start]fillers[blank_end], [blank_start]lubricants[blank_end], and [blank_start]glidants[blank_end] to the active ingredients to facilitate encapsulation. • The addition of wetting agents to the powder mass is common where the active ingredient is [blank_start]hydrophobic[blank_end]

• [blank_start]Disintegrants[blank_end] also may be included in powder formulations to facilitate [blank_start]deaggregation[blank_end] and dispersal of capsule plugs in the [blank_start]gut[blank_end].

[blank_start]Inert sugar beads[blank_end] may be coated with active ingredients and coating compositions that provide extended-release profiles or [blank_start]enteric[blank_end] properties.

Alternatively, larger-dose active ingredients themselves may be suitably formed into [blank_start]pellets[blank_end] and then [blank_start]coated[blank_end]

Since gelatin is of animal origin and starch is of vegetable origin, capsules made with these materials should be protected from potential sources of [blank_start]microbial contamination[blank_end].

Disadvantages: • Can’t be used for drugs that [blank_start]solubilize gelatin[blank_end] • Not suitable for [blank_start]hygroscopic[blank_end] drugs • Not suitable for [blank_start]deliquescent[blank_end] drugs • Potential for leaking

[blank_start]Deliquescent[blank_end] - becoming liquid or having a tendency to become liquid

Capsules have fewer excipients than tablets, they contain: • [blank_start]Drug[blank_end] • [blank_start]Filler[blank_end] • [blank_start]Lubricant[blank_end]

Capsule shell is made of: • Gelatin • [blank_start]Water[blank_end] • [blank_start]Colorants[blank_end] • Opacifying Agents • [blank_start]Preservatives[blank_end] • Miscellaneous ingredients

• Gelatin is prepared by the [blank_start]thermal denaturation[blank_end] of collagen, isolated from animal skin and bones, with very [blank_start]dilute[blank_end] acid or base (gelatin A or B).

Gelatin contains a large number of [blank_start]glycine[blank_end], [blank_start]proline[blank_end] and 4-[blank_start]hydroxyproline[blank_end] residues

Hard-shell capsules: • They normally contain between [blank_start]10[blank_end]% and [blank_start]15[blank_end]% water. • The empty capsules should be stored in tight containers until they are filled.

[blank_start]Punch Method[blank_end]: Procedure for weighing capsules with an electronic balance. 1. Place the balance on a smooth, level surface. Press the tare button and observe the balance set at 000.0. 2. Place a weighing paper and an empty capsule shell of the appropriate size on the balance pan. Re-zero the balance by pressing the tare button. The digital display should read 000.0 After this step, do not touch the tare button again during this weighing operation. 3. Remove the empty capsule shell from the balance pan. The digital display will read a negative value which represents the weight of the capsule shell. 4. For each capsule, punch powder into an empty capsule shell and place it on the balance pan. Add or remove powder to the capsule shell until the digital display shows the desired weight of the capsule powder.

The uniformity of dosage units can be demonstrated by either of two methods, [blank_start]Content Uniformity[blank_end] or [blank_start]Weight Variation[blank_end]

[blank_start]Soft Elastic Capsules[blank_end] can not be prepared in the pharmacy

For soft-gel capsules, a [blank_start]rupture[blank_end] test is conducted in a dissolution apparatus using [blank_start]500[blank_end] mL water and [blank_start]50[blank_end] rpm paddle speed. If the capsule ruptures within [blank_start]15[blank_end] minutes, the test is passed

[blank_start]Microencapsulation[blank_end]: process or technique by which thin coatings are applied to small particles. - This is used for very [blank_start]sensitive[blank_end] drugs