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level questions: Level 1

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are solid dosage forms in which medicinal agents and/or inert substances are enclosed within a small shell of gelatin. Gelatin capsule shells may be hard or soft depending on their composition.Capsules
Administration route of capsulesOrally (whole or mixed with food or drink after opening capsules)
ADVANTAGES OF CAPSULES FOR ORAL ADMINISTRATION1. conveniently carried 2. readily identified 3. easily taken 4. prescribing flexibility 5. Efficiently and productively manufactured 6. Packaged and shipped at lower cost and with less breakage 7. More stable and have a longer shelf-life 8. Empty hard gelatin capsules are often used in the extemporaneous compounding of prescriptions. 9. Tablets and capsules are sometimes used as the source of a medicinal agent when it is not otherwise available.
TYPES OF CAPSULESHard gelatin capsules Soft gelatin capsules
1 Shells of capsules may be composed of __1 two pieces ( body and cap) 2 single piece
Applications: used to manufacture most medicated agents employed in clinical trials used in the extemporaneous compoundingHARD GELATIN CAPSULES
HARD GELATIN CAPSULES empty capsule shells consist of:1 gelatin, 2 sugar, 3 water, 4 colorants (various dyes), and 5 opaquant (titanium dioxide). Pneumonics: GSW CO
1 Gelatin is obtained by __ 2 HARD GELATIN CAPSULES Commerce 3 Normally, hard gelatin capsules contain between __ moisture 4 If hard gelatin capsules absorbed additional moisture: 5 If hard gelatin capsules lose their contained moisture: 6 (dried silica gel, clay, and activated carbon)1) partial hydrolysis of collagen 2) available in the form of fine powder, coarse powder, shreds, flakes or sheets 3) 13 to 16% 4) become distorted and lose their rigid shape 5) become brittle and crumble when handled 6 Dessicant
The solubility property of gelatin:Insoluble cold water: soften through the absorption of up to ten times its weight of water soluble in hot water and in warm gastric fluid. Gelatin, being a protein, is digested by proteolytic enzymes.
METHODS USED TO TRACK THE PASSAGE OF CAPSULES IN GIT1 Gamma scintigraphy 2 Heidelberg capsule
1 Noninvasive procedure use of a gamma ray-emitting radiotracer incorporated intro the formulation with gamma camera coupled to a data recording system.1 GAMMA SCINTIGRAPHY
GAMMA SCINTIGRAPHY METHOD IS USEFUL IN:1 Determining whether correlation exist between in vivo and in vitro bioavailability of immediate release product 2 Assessing the integrity and transit time of enteric coated tab through stomach en route to the intestines 3 Drug and dosage form evaluation in new product development
pH sensitive nondigestible radiotelemetric device Approximate size is No. 0 gelatin capsule Nonradioactive means to measure gastric pH, gastric residence time, gastric emptying time of solid dosage forms in fasting and non fasting human subjectsHEIDELBERG CAPSULE
Heidelberg pH diagnostic systems are used for:1 Long Term Migratory Studies 2 Pharmacokinetic Research and Clinical Research on Animals and Humans Major Pharmaceutical Companies use this system Researchers rely on this system
THE MANUFACTURE OF HARD GELATIN CAPSULE SHELLS The process of capsule shell production with the peg/pin method:dipping→ drying → stripping→ trimming→ joining a) The thickness of the gelatin walls must be strictly controlled. b) The caps are slightly larger in diameter than the bodies. Pneumonic: DDSTJ
THE MANUFACTURE OF HARD GELATIN CAPSULE SHELLS Some improvements to hard gelatin capsule shells 1 rounded shape 2 tapered end pegs 3 Bodies and caps highly tapered1 cap 2 Pulvules 3 Spansule capsules
1 Tapered rim to avoid telescoping 2 Grooves which lock the two halves together once the capsule has been filled1 CONI-SNAP 2 SNAP-FIT
THE MANUFACTURE OF HARD GELATIN CAPSULE SHELLS Tamper-evident sealing through various capsule sealing techniques Imprinting: __a) names and monograms of the manufacturer b) the assigned national drug code (NDC) number c) other markings making the product identifiable and distinguishable from other products
CAPSULE SIZES How to select capsule size?1) the amount of fill material to be encapsulated 2) the density and compressibility of the fill 3) The final determination largely may be the result of trial.
The sizes of empty capsules 1 For human use: 2 For veterinary use:1) 000(the largest), 00, 0, 1, 2, 3, 4, 5 (the smallest) 2) Larger capsules are available.