Capsules

A solid dosage form in which unit-doses of powder, semisolid, or liquid drugs are enclosed within a hard or soft gelatin envelope or shell

• Most versatile of all dosage forms
• Elegant, convenient, and easily identifiable
• Dosing flexibility for the physician
• Available in many different sizes, shapes, and colors
• Specific products for individual patient needs
• Conceal odor and taste of drugs
• Patients who cannot swallow a tablet but can swallow a capsule (encapsulate the tablet)
• Combination of several drug products into one capsule- increased compliance
• Relatively easy to manufacture
• Amenable to small-scall compounding by the pharmacist

Theo-Dur

• Unit-dose
• Pre-measured medicinal powder

• Hard Gelatin
• Soft Gelatin

Hard Gelatin

• Can be prepared to release the drug rapidly or over a predetermined time
• Can be opened and adminstered with food or liquids
• Allows encapsulation of solids, semisolids, and non-aqueous liquids
• Allows the prepartion of capsules within capsules and tablets within capsules

Gelatin, Sugar, Water

• Have:
• High Humidity (distored and loses rigid shape)
• High Dryness (brittle and crumbling)
• Can be colored with dyes or opaque (titanium dioxide)

• Body or base (longer, with smaller diamer; holds required amount of powder)
• Cap or top (shorter, with slightly larger diameter; ensures powder retention only
• *Overlap when joined together. Cap fits snugly over the open end of the body, have tapered ends to avoid splitting

• May vary in length, diamer, capacity
• Determined b the amount of fill material to be encapsulated (Density and compressibility, initially approximate size, use trial and error for final determination)
• Sizes vary from 000 to 5

000

5

Prepare a capsule with accurate dosage, good bioavailability, ease of filling and production, stability and elegance

• Developing and preparing the formulation and selecting size capsule
• Filling the capsule shells
• Capsule sealing (optional)
• Cleaning and polishing the filled capsules

drugs

• Lactose, starch, mannitol, cellulose derivatives
• For bulk and cohesion

• Mg carbonate, Mg oxide
• to separate compounds that may liquefy upon interaction

• pre-gelatinized starch, croscarmellose, sodium starch glycolate
• To assit the breakup and distribution of contents in the stomach

Comminution, Milling, Micronization

Add drops of alcohol, water or mineral oil

• Hand Filling (punch) Method
• Capsule Filling Machines
• Automated capsule filling machines

• *Never touch powder!
• Powder mixture arranged on a sutable surface as a powder "cake" (cake formed with thickness of the pile about 1/3 the length of the capsule body)
• Capsule body pressed into the powder until slight resistance is felt
• Check weight of capsules
• If powders do not stick inside the capsules when punched out, the capsule body can be placed on its side and a spatula is used to fill the body with powder

• Manually operated filling devices for 50, 100, or 300 caps
• Block off unused holes
• Powder is spread evenly into the capsules bodies with the help of plastic spatual
• Device is closed and caps will fit snugly over the bodies

• Automated capsule filling machines
• (Fill, weigh, polish, count and distribute into containers or unit dose or strip packaging)

• Material sufficiently plastic
• Role into a pip, cut with spatual or knife, weigh, encole in shell. COrstarch for firmer consistency
• If material has satisfactory melting poing (Warm melt poured into capsule bodies, wood stand)

• Vegetable oils
• vegetable fats
• animal fats
• hydrocarbons
• fatty alcohols
• fatty acids
• esters

• Sporadically used
• Liquid material must not dissolve the gelatin
• Fixed oils, volatile oils, alcoholic solutions: gelatin is not solube
• Liquid material added with micropipette, calibrated dropper, or syringe
• Selaing of body and cap is madeatory
• Prior to packaging capsules should be placed on a clean, dry sheet of paper to check for leakage.

• prevent leakage and tampering
• FDA regulations (1982 and 1986 cyanide placed in capsules)

• Touch the gelatin cap open end down to a moist towel
• Dip a cotton swab in warm water and rub it around the edge of the cap
• Painting of warm gelatin solutions inside of the capprior to its placement on the base and outside at body and cap junction

• Banding (gelatin or polymer band)
• Tamper resistant sealing (contact areas of cap and body wetted with diluted alcohol then heated at approx. 50 C
• Snap fit (body and cap joined through locking grooves)

For appearance and absence of taste

Vacumm

Clean gauze or cloth

• liquids
• suspensions
• powders

• Usually provide standard release of the drug
• Used as unit-dose only (MyQuil Liquicaps, Tessalon perles)
• Allow encapsulation of liquids, suspensions or powders

Gelatin (glycerin and or sorbitol) and water

• Elastic capsules
• Softgels
• Liquicaps
• Perles

• Very specialized equipment
• Liquid, paste, and dry fills

• Added substances
• containers
• disintegration test
• dissolution test
• weight variation
• content uniformity
• content labeling
• stability testing
• moisture permeation test