CAPSULES-notes-2010 - University of Wyoming PHCY 6100 Solid...

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Unformatted text preview: University of Wyoming PHCY 6100 Solid Dosage Forms: CAPSULES 1. Def. Solid dosage forms in which unit-doses of powder, semisolid, or liquid drugs are enclosed within a hard or soft gelatin envelope or shell. 2. Uses A) As unit-dose B) As pre-measured medicinal powder i. ii. 3. To be sprinkled on food: Theo-Dur® sprinkle To be opened and contents mixed with food or drink for ease of swallowing. Advantages A) Most versatile of all dosage forms B) Relatively easy to manufacture C) Amenable to small-scale compounding by the pharmacist D) Preparation of specific products for individual patient needs E) Dosing flexibility for the physician F) Can be prepared to be elegant, convenient, and easily identifiable G) Available in many different sizes, shapes and colors H) Conceal odor and taste of drugs I) For patients who cannot swallow a tablet but can swallow a capsule (encapsulated tablet) J) Combination of several drug products into one capsule will increase compliance K) Portability, light weight, rapid drug release 4. Types A) Hard gelatin capsules (1846-48) i. Most common type ii. Can be prepared to release the drug rapidly or over a predetermined time iii. Can be opened and administered with food or liquids iv. Allow encapsulation of solids, semisolids and nonaqueous liquids v. Allow the preparation of capsules within capsules and tablets within capsules B) Soft gelatin capsules (1833) i. ii. Used as unit-dose only iii. 5. Usually provide standard release of the drug Allow encapsulation of liquids, suspensions or powders. Hard gelatin capsules A) Teixeira SHELL 1 University of Wyoming PHCY 6100 Solid Dosage Forms: CAPSULES i. Gelatin + sugar + water (13-16%) ii. High humidity: loss of shape iii. High dryness: crumbling iv. Parts: a) Body or base (longer, with lesser diameter; holds required quantity of powder) b) Cap (shorter, with a slightly larger diameter; used to ensure powder retention, only). c) The cap slides over the body and forms a snug seal. v. Shapes vi. Colors (dyes) or opaque (titanium dioxide) B) Capsule size i. May vary in length, diameter, capacity ii. Choice of a capsule size depends on the amount of fill material (density and compressibility); trial and error. iii. Capsules for human use vary from #000 (the largest) to #5 (the smallest) iv. Individual patient’s needs: larger sizes (swallowing problems) x smaller sizes (hard to handle by elderly) = use pharmacist’s common sense! C) Preparation i. Weighing/measuring of ingredients a) Active ingredients b) Fillers: lactose, starch, mannitol, cellulose derivatives, etc, for bulk and cohesion. c) Absorbants: Mg carbonate, Mg oxide, to separate compounds that may liquefy upon interaction. d) Disintegrants: pregelatinized starch, croscarmellose, sodium starch glycolate, to assist the breakup and distribution of contents in the stomach. e) Other excipients: as needed. ii. Blending: low-dose drugs by geometric dilution. iii. Particle size reduction: to approximately the same size range for uniform distribution; comminution, milling, micronization. iv. If powders are very light and fluffy, add a few drops (1-2) of alcohol, water or mineral oil OR mix the powders in a zip-type bag. Remember personal safety (mask, gloves, etc). D) Encapsulation process Individual hand filling or “punch” method: for powders. i. a) Teixeira Hands should not touch the powder when punching: use gloves or finger cots 2 University of Wyoming PHCY 6100 Solid Dosage Forms: CAPSULES b) Powder mixture is arranged on a suitable surface c) Using a spatula, a powder “cake” is formed so that the thickness of the pile is about one third the length of the capsule body. d) Capsule body is pressed into the powder until a slight resistance is felt (development of a feel for how much resistance is required for the capsule to be full). e) Check weight of capsules (use empty capsule as tare): potent drugs f) If powders do not stick in the capsules when punched out, the capsule body can be placed on its side and a fine spatula is used to guide or fill the powder. g) Granular materials may need to have particle size reduction to be encapsulated. ii. Capsule filling machines a) Manually operated capsule filling devices: 50, 100 or 300 caps (block off unused holes with an index card or post-it) b) Powder is spread evenly into the capsules bodies with the help of a plastic spatula. iii. Large scale a) Automated capsule-filling machines b) Fill, weigh, polish, count and distribute into containers or unit-dose or strip packaging. iv. Filling capsules with a semisolid mass a) Different approach is required • Material (if sufficiently plastic) is rolled into a pipe with a diameter slightly less than that of the inner diameter of the capsule. Quantity desired is cut with a spatula or knife, weighed, enclosed in shell. Cornstarch is used to get a firmer consistency if the material is too fluid. • Material is melted (if satisfactory melting point) until fluid then poured into capsule bodies. Use a wood stand. b) Different excipients are used as matrices: Vegetable oils (cotton seed, olive, and soya), vegetable fats (cocoa butter, carnauba wax), animal fats (beeswax, lanolin, and spermaceti), hydrocarbons (paraffin), fatty alcohols (cetyl, lauryl, and stearyl), fatty acids (lauryl, palmitic, stearic), esters (ethyl oleate, glycol stearates). c) This method can also be used to enhance the bioavailability of drugs that are poorly soluble. Drug is added to a melt of PEG 6000 + 8000, mixed thoroughly, and poured or measured using a pipet, syringe or calibrated dropper. v. Filling capsules with liquids a) Occasionally used b) Liquid material must not dissolve the gelatin Teixeira 3 University of Wyoming PHCY 6100 Solid Dosage Forms: CAPSULES c) Fixed oils, volatile oils, alcoholic solutions: gelatin is not soluble d) Liquid material is measured accurately with a micropipette, calibrated dropper, or syringe. e) Sealing of body and cap is mandatory f) Prior to packaging, capsules should be placed on a clean, dry sheet of paper to check for leakage. E) Sealing of filled capsules: i. FDA regulations (1982, 1986 - cyanide in acetaminophen) ii. To prevent leakage and tampering iii. Compounding: touch the gelatin cap open end down to a moist towel or dip a cotton swab in warm water and rub it around the edge of the cap. iv. Manufacturing: v. Banding: body and cap are secured by a gelatin or polymer band (manufacturer level) or by painting a warm gelatin solution around the capsules as well as along the inside of the cap prior to its placement on the base (compounding level). vi. Tamper-resistant sealing: contact areas of cap and body are wetted with diluted alcohol then heated at approx. 50°C. vii. Snap-fit™ principle: body and cap are joined through locking grooves designed on shell parts; works well also with hand-operated capsule-filling machines. F) Cleaning and polishing: i. ii. Large scale: by vacuum iii. 6. For appearance and absence of taste. Small scale: clean gauze or cloth Soft gelatin or elastic capsules, Softgels, Liquicaps® A) SHELL i. B) Gelatin + Glycerin or sorbitol + Water Preparation and uses i. ii. 7. Very specialized equipment (plate process or rotary/reciprocating die processes). Liquid, paste and dry fills Compendial Requirements A) Added substances B) Containers C) Disintegration test D) Dissolution test Teixeira 4 University of Wyoming PHCY 6100 Solid Dosage Forms: CAPSULES E) Weight variation F) Content uniformity G) Content labeling H) Stability testing I) Moisture permeation test Teixeira 5 ...
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