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
Tablets ingested orally
Compressed tab (Actaminophen) Multiple compressed tab (tab inside tab) Repeat action Delayed release (enteric coated bisacodyl tab) Sugar coated (multivit) Film coated (metronidazole) Chewable tab (antacid)
Tablets used in Oral Cavity
Buccal (Vitamin-C tab) Sublingual tab (Vicks Menthol tabs)
Vaginal tablets
aka “inserts”
Made by compression, comes with insertion device
Tablets used to prepare solution
Effervescent tablet (Aspirin)
Common tablet excipients
Diluents Binders or adhesives Disintegrants Glidants Lubricants Antiadhesives
Diluents
Increase bulk and enhance compression
Binders or Adhesives
Promote adhesion of the particles in the formulation
Disintegrants
Promote breakup of tablets in GI
Glidants
Improve flow properties
Lubricants
Reduce friction during tablet compression
Antiadhesives
Prevent tablets from sticking to equipment
Multiple compressed Tablets
Tablet w/in Tablet: If two component not compatible
Layered Tablet: One side can do burst, other sustain
Prepared by subjecting fill material to more than 1 compression
Sugar - Coated Tablets
compressed tablets coated with sugar coating
Long process of laying, multiple coats
Barrier to taste/odor and protects drug from air/water
Film - Coated Tablets
Compressed tablets with polymer coating layered onto the tablet as a thin film
durable, less bulky and time consuming compared to sugar coated
Gelatin - Coated Tablets
Helps facilitate swallowing and more tamper evident
GELPCAP: Capsule-shaped, compressed tablet that is coated with a thin layer of gelatin
Enteric - Coated Tablets
Delayed release
Coating generally dissolves in a higher pH range
Protects drug at acidic pH range
Buccal and Sublingual Tablets
Bypass liver, directly into systemic circulation very fast
Protects from gastric juices, alternative for drugs poorly absorbed GI tract
Designed to be dissolved in cheek (Buccal pouch) or under tongue (sublingual)
Lozenges and troches
Solid dosage form with medical agent in hard candy or sugar base intended to be dissolved oral cavity for local effects
Fentanyl lollipops made for cancer pain by compounding pharmacy
Chewable Tablets
For children, adults who have trouble swallowing
Flavoring important (Mannitol + other sweeteners)
Must be chewed for rapid disintegration, not swallowed.
Effervescent Tablets
Compressed tabs with effervescent salt that release carbonation when put in water
Molded tablets
can be made by molding without compression, extemporaneously made.
Soft and dissolve rapidly
Rapidly disintegrating or Dissolving Tablets
Lyophilized Foam:
mixture poured into mold and freeze dried, mold becomes package.
Zofran ODT
Compression:
Mildly compressed tablets containing super-disintegrants
Extended - Release tablets
Mechanism used in tabs or capsules to…
affect rate of drug release
slow transit time of drug through GI tract
Reduces dose frequency, and less change in blood levels
Imprinting of tablets/capsules
Required by FDA for drugs intended for human use, Rx and OTC
Product specific ID codes
Exempt drugs - investigational, compounded, radiopharmaceuticals, and ones you can imprint
Desirable Characteristics of Compressed Tablets
Hardness = 5-6kg Thickness = 2.0 mm Weight = 200 mg +/- 5% Content uniformity = 95 - 102% Disintegration = < 5min
Film coating
thin coat of plastic like material over tab, resistant to abrasion and imprint/shape/size retained
Aqueous coating preferred
Enteric Coatings
Designed to dissolve at pH of 4.8 or higher
Has a bunch of layers, like an onion
Packaging and storage
Tight containers, in places of low humidity and no extreme temps
Desiccant used if med prone to decomp by moisture
Light resistant for light sensitive
Extended Release Tech
Multitablet system has small spheres coated for various release times
Ion-exchange resin released drug based on pH and electrolyte conc in GI tract
Osmotic Pump
Tablet surrounded with a semipermeable membrane with a 0.4 mm diameter hole made with laser
Once swallowed, water enters the tablet and forces the solution out using osmotic pressure
Lake pigemnts
Synthetic insoluble colorants
insoluble material in aqueous solutions that colors by dispersion
Made by precipitating and adsorbing water-soluble dye onto a substrate, usually calcium and aluminum salts
Lake colors
Used in cosmetic and food industry
They are oil soluble
Used in edible products
Tablet Compendia Requirements
Thickness - done by die and pressure Hardness Friability - tendency to crumble Content uniformity and weight variation disintegration - 2 - 30 min Dissolution
