DDS 3.2 CAPSULES

are dosage forms in which one or more medicinal and/or inert substances are enclosed within a small shell of gelatin.

composed of two pieces: longer body, shorter cap

single piece; usually liquid inside

1. May be swallowed whole by the patient
o ROA: oral route
o Premeasured medications: capsule is formulated for a single dose, do not need to be divided anymore
2. May be inserted into the rectum for drug release and absorption from the site (soft gel capsule)
3. The contents may be removed from the gelatin shell
o External application of the contents
4. Elegant – different colors  identifiable to other dosage forms
5. Ease of use – easily taken by the patient
6. Portability – can be conveniently carried
7. Tasteless shell to mask the unpleasant taste/odor of drug
o Helps in patient compliance
8. Permits physician to prescribe the exact medication needed by the patient
o Available in a variety of dosage strengths
o Provides flexibility for the physician to select
9. Readily identified
o Colored, embossed, imprinted with the manufacturer’s name and product code
o Helps in comparing FDA-approved and counterfeits
10. Packaged and shipped by manufacturers at lower cost
11. More stable and longer shelf life
o Unlike liquid forms, capsules have less breakage tendencies  easily manufactured and transported

• Dry Filled Capsules “DFC”

• Made up of gelatin, sugar, and water
• Longer capsule body and a shorter cap
• Clear, colorless, tasteless – gelatin capsule shell

is the preparation of the drug product in the pharmacy, community pharmacy or in the hospital pharmacy. Capsules are preferred because of their simplicity in preparation.

obtained by partial hydrolysis of collagen from the skin, white connective tissue, and bones of animals

13 to 16% moisture but may vary depending on the storage condition

colorant used for hard gelatin capsule

Opacifying agent used in Hard gelatin capsule

o To make them more distinctive and easily identified

• Insoluble but softens in cold water (absorption of water up to 10x its weight of water), soluble in hot water and warm gastric fluid
• Digested by proteolytic enzymes (gelatin is a protein)
• Easier to swallow than tablets  wetted in water, easily slide down the throat

– distorted and lose their rigid shape

brittle and crumble

straight-walled body and straight-walled capsule

– has a locking groove that snaps when closed  helps in the joining and reliable closing of the filled capsule; the capsule cannot be opened easily

– has a locking groove and its walls are not straight (ends are slightly tapered)  reduces the pressure and impact when the capsule and the body are put together; lesser tendency to telescope

but its closure can extend deeper down the body  leaving us with a small gripping area of the body  cannot be opened easily, increasing the security of the contents of the capsule

lock the two capsule parts together after the capsule has been

avoid telescoping

prevent premature opening

This method used in manually filling hard capsules

allow air to escape from the cap; critical when operating high speed filling machines

provide full-circumference leak-free closure

– engages easily with the cap for problem-free closure

– maintain precise round capsule diameter, improving filling machine performance

unauthorized alteration of drugs

Lactose, microcrystalline cellulose, and starch

pregelatinized starch, croscarmellose, and sodium starch glycolate.

as fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid, or talc (about 0.25% to 1%)

Because the amount of powder packed into a capsule depends on the degree of compression, the pharmacist should _______ each capsule in the same manner and weigh the product after capping

It is designed for one (1) capsule size.

Soft Elastic Capsule

• May be oblong, oval or round
• May be single colored or two toned
• May be imprinted with identifying markings
• Described as pharmaceutically elegant and easily swallowed

a warm sheet of plain or colored gelatin is placed on the bottom plate of the mold, and the medication-containing liquid is evenly poured on it. Then a second sheet of gelatin is carefully placed on top of the medication, and the top plate of the mold is put into place. Pressure is then applied to the mold to form, fill, and seal the capsules simultaneously. The capsules are removed and washed with a solvent harmless to the capsules.

liquid gelatin flowing from an overhead tank is formed into two continuous ribbons by the rotary die machine and brought together between twin rotating dies.

Vegetable and aromatic oils, aromatic and aliphatic hydrocarbons, chlorinated hydrocarbons, ethers, esters, alcohol and organic acids

Polyethylene glycols, nonionic surface active agents such as polysorbate 80

Propylene glycol and isopropyl alcohol, depending upon factors as concentration used and packaging conditions

1. Water above 5%
2. Low MW (molecular weight) water-soluble and volatile organic compounds such as alcohols, ketones, acids, amines, and esters

• Should have a uniform appearance
• Defective capsules should be rejected
• Capsules may be counted manually or automated equipment
• Trays must be wiped clean after each use
• Containers are then mechanically capped, inspected visually or electronically, labeled, and inspected once more
• Packaged in glass or in plastic containers (with desiccant suc as dry silica gel, clay. and/or activated charcoal)
• Stored in tightly capped containers in a cool, dry place

– automatic tablet and capsule counting and filling apparatus

can occur with dry ingestion

Ranitidine HCl
Acetazolamide

Myra E (d-Alpha Tocopherol), Advil (Ibuprofen), Robitussin (Guaifenesin)

Amoxicillin (RiteMed), Rifam (Rifampicin)