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What is the definition of a capsule?
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
What are the advantages of capsules?
- 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
What is a medication that is a pre-measured medicinal powder to be sprinkled on food?
How are contents of capsules packaged?
- Pre-measured medicinal powder
What are the types of capsules?
What are the most common types of capsules?
What are some advantages of hard gelatin capsules?
- 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
What are shells of Hard gelatin caspules composed of?
Gelatin, Sugar, Water
Shells of hard gelatin capsules...
- High Humidity (distored and loses rigid shape)
- High Dryness (brittle and crumbling)
- Can be colored with dyes or opaque (titanium dioxide)
Hard Gelatin capsules come in two parts, what parts?
- 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
What is the largest capsule size for human use?
What is the smallest capsule size for human use?
What is the goal of hard gelatin capsule preparation?
Prepare a capsule with accurate dosage, good bioavailability, ease of filling and production, stability and elegance
What are the four steps in the preparation of filled hard gelatin capsules?
- Developing and preparing the formulation and selecting size capsule
- Filling the capsule shells
- Capsule sealing (optional)
- Cleaning and polishing the filled capsules
What are active ingredients?
What are diluents and fillers?
- Lactose, starch, mannitol, cellulose derivatives
- For bulk and cohesion
What are absorbants?
- Mg carbonate, Mg oxide
- to separate compounds that may liquefy upon interaction
What are disintegrants?
- pre-gelatinized starch, croscarmellose, sodium starch glycolate
- To assit the breakup and distribution of contents in the stomach
Particle size is reduced by?
Comminution, Milling, Micronization
If powders are light and fluff what should be done?
Add drops of alcohol, water or mineral oil
What are the encapulation processes?
- Hand Filling (punch) Method
- Capsule Filling Machines
- Automated capsule filling machines
What is the "punch" method?
- *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
How do capsule filling machines work?
- 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
On a large scale how are capsules mad?
- Automated capsule filling machines
- (Fill, weigh, polish, count and distribute into containers or unit dose or strip packaging)
How are capsules filled with semisolid mass prepared?
- 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)
What excipients are required when making a semisolid capsule fill?
- Vegetable oils
- vegetable fats
- animal fats
- fatty alcohols
- fatty acids
What should be known about filling capsules with liquids?
- 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.
Why are capsules sealed?
- prevent leakage and tampering
- FDA regulations (1982 and 1986 cyanide placed in capsules)
How are capsules sealed when compouneded
- 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
How are capsules sealed with manufactured?
- 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)
Why are capsules cleaned and polished?
For appearance and absence of taste
How are capsules cleaned and polished on a large scale?
How are capsules cleaned and polished on a small scale?
Clean gauze or cloth
Soft gelatin capsules allow for the encapsulation of?
Soft Celatin Capsules?
- Usually provide standard release of the drug
- Used as unit-dose only (MyQuil Liquicaps, Tessalon perles)
- Allow encapsulation of liquids, suspensions or powders
What do soft gelatin capsules consist of?
Gelatin (glycerin and or sorbitol) and water
What are the different types of soft gelatin capsules
- Elastic capsules
What are the preparation and uses of soft gelatin capsules
- Very specialized equipment
- Liquid, paste, and dry fills
What are the compendial requirements for capsules
- Added substances
- disintegration test
- dissolution test
- weight variation
- content uniformity
- content labeling
- stability testing
- moisture permeation test