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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
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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
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What is a medication that is a pre-measured medicinal powder to be sprinkled on food?
Theo-Dur
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How are contents of capsules packaged?
- Unit-dose
- Pre-measured medicinal powder
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What are the types of capsules?
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What are the most common types of capsules?
Hard Gelatin
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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
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What are shells of Hard gelatin caspules composed of?
Gelatin, Sugar, Water
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Shells of hard gelatin capsules...
- Have:
- High Humidity (distored and loses rigid shape)
- High Dryness (brittle and crumbling)
- Can be colored with dyes or opaque (titanium dioxide)
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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
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Capsule sizes
- 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
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What is the largest capsule size for human use?
000
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What is the smallest capsule size for human use?
5
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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
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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
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What are active ingredients?
drugs
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What are diluents and fillers?
- Lactose, starch, mannitol, cellulose derivatives
- For bulk and cohesion
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What are absorbants?
- Mg carbonate, Mg oxide
- to separate compounds that may liquefy upon interaction
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What are disintegrants?
- pre-gelatinized starch, croscarmellose, sodium starch glycolate
- To assit the breakup and distribution of contents in the stomach
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Particle size is reduced by?
Comminution, Milling, Micronization
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If powders are light and fluff what should be done?
Add drops of alcohol, water or mineral oil
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What are the encapulation processes?
- Hand Filling (punch) Method
- Capsule Filling Machines
- Automated capsule filling machines
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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
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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
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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)
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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)
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What excipients are required when making a semisolid capsule fill?
- Vegetable oils
- vegetable fats
- animal fats
- hydrocarbons
- fatty alcohols
- fatty acids
- esters
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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.
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Why are capsules sealed?
- prevent leakage and tampering
- FDA regulations (1982 and 1986 cyanide placed in capsules)
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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
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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)
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Why are capsules cleaned and polished?
For appearance and absence of taste
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How are capsules cleaned and polished on a large scale?
Vacumm
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How are capsules cleaned and polished on a small scale?
Clean gauze or cloth
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Soft gelatin capsules allow for the encapsulation of?
- liquids
- suspensions
- powders
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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
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What do soft gelatin capsules consist of?
Gelatin (glycerin and or sorbitol) and water
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What are the different types of soft gelatin capsules
- Elastic capsules
- Softgels
- Liquicaps
- Perles
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What are the preparation and uses of soft gelatin capsules
- Very specialized equipment
- Liquid, paste, and dry fills
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What are the compendial requirements for capsules
- Added substances
- containers
- disintegration test
- dissolution test
- weight variation
- content uniformity
- content labeling
- stability testing
- moisture permeation test
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