Exam 2 - Powerpoint 2 (Capsules) Flashcards
Capsules
“Unit doses of powder, semisolid or liquid drugs enclosed within either a hard or soft envelope, or shell”
Types of Capsules
Gelatin (Hard and Soft)
Vegetable
Advantages of capsules
Convenience compared to a liquid Easy to identify with colors or markings No need for spoons or other measuring devices Tasteless Allows flexibility in dosing Easy to transport Easy to take Manufacturing cost is low with minimal breakage Longer stability than liquid dosage form
Hard Gelatin Capsules
Components (Gelatin, sugar, H2O)
may be colored (FD&C + D&C dyes)
may be opaque (titanium dioxide)
Gelatin is soluble in hot water and gastric fluid
Protect from moisture using desiccants in the packing
Capsule Identification
size, shape and color are visual characteristics
Brand identification, quality perception, counterfeit prevention
Dye
Chemical that shows color when it is dissolved in an aqueous base, not oil base
Can “bleed” or migrate from one part of a product to another
FD&C, D&C, External D&C
Capsule Preparation Steps
Comminution Blending Determine capsule size Add additional diluent as needed Encapsulate Clean Quality control Package and label
Coni-Snap Capsules
Fill the “body” of capsule
Cap has a ring that locks into dimple on the body when its fully locked
How to select capsule size?
Choice depends on amount of material, compressibility and density
Capsule # 000 more for vet use, very big rare for people
increasing #, smaller the mg content
Diluents or adsorbents
provide bulk to the formulation, can reduce moisture
Ex. Lactose, cellulose
Disintegrates
to assist in the break-up and distribution of the capsule contents
Ex. pre-gelatinized starch
Glidants
enhance the flow properties of the powder mix
Ex. silicon dioxide, talc
Wetting agents
Faciliate wetting of the dry powder
Ex. surfactant
Wetting agents
Faciliate wetting of the dry powder
Ex. surfactant
Capsule within a capsule
For potent, small dose powders
For separation of incompatible ingredients
Altered release capsules (part gives burst, other helps sustain)
Capsule Closures
Extemporaneous Compounding:
use hydroalcoholic solution to seal
hot pin
Manufactoring:
Gelatin band (KAPSEALS)
Heat Welded band or thermally coupled
Soft Gelatin Capsules Components
Gelatin, Plasticizers, Colorants/ Opaquants, Preservatives (for microbial growth)
easy to swallow
Encapsulate and hermetically seal liquids
Capsule compendial Requirements
Disintegration Tests
Dissolutions Tests
Content Uniformity and Weight Variation
stability tests
Tablets
solid dosage forms contains medical substances with or without suitable excipients
Tablet info
Most frequently prescribed dose
Can be manufactured at a rate of thousands/min
Can be scored or grooved, engraved or imprinted, many different shapes
Tablet advantages
Accurate dosage/minimum variability Concentration variability Elegance Low Cost Easiest/cheapest to package and ship Product identification is simple Ease of administration Special release profiles possible Suited for large-scale production
Tablet disadvantages
Absorption by the patient can vary
Pediatric and geriatric patients cant swallow
Bitter tasting drugs need coating
GI irritation
Hydroscopic drugs are not suitable for tablets
Low density and amorphous are difficult to compress