Used to improve flowability Coat powder particles Fill surface irregularities and reduce the roughness Keep particles separated and reduce attractive forces Modify electrostatic charges Act as moisture scavengers Serve as ball bearing between host particles Example of glidants oColloidal silicas oTalc oMagnesium stearate
Capsule powder formulation Lubricants Helps eject plugs Reduce filming on pistons and adhesion of powders to metal surfaces Reduce friction between sliding surfaces Increase in the hydrophobic lubricants retard drug release. Typical lubricants are oMagnesium stearate oStearic acid
Capsule powder formulation Surfactants Increase the wetting of powder mass and enhance dissolution. Sodium lauryl sulfate sodium docusate Hydrophilization: Hydrophilic polymers increase the wettability of poorly soluble drugs. oMethylcellulose oHydroxymethyl cellulose
Hard gelatin capsule size and filling possibility
Capsule filling process Blending of ingredients Excipients and active ingredients are blended Loading of capsules Empty capsules are oriented toward the same direction Usually body-end down ward. Separation of caps and bodies A vacuum applied from below to separate body from the caps.
Automated filling process capsule Dosing of fill material Capsule powder is filled into the capsule body Replace the cap and eject the filled capsules The cap and body portion are rejoined Compressed air ejects filled capsules Cleaning and polishing Filled capsules are cleaned and polished to remove powders adhere to shell surface
Flow diagram of automated capsule filling
Quality assurance for hard gelatin capsules Uniformity of mass and content Capsules are checked for homogeneity in weights Chemical analysis is performed to check the uniformity of the dosage. Disintegration All capsules are checked if the shell and content of the capsules break apart in a reasonable time period. Disintegration tester
Quality assurance for hard gelatin capsules Dissolution testing: Measure the rate at which drug is released from the capsule. Each product should be tested according to the book specifications. Dissolution tester
CAPSULE FROM MANUFACTURER TO PHARMACIST Raw Materials/Capsule shell Storage Quality control Weighing Mixing Quality control Quality control Quality control Filling Polishing Packing Finished capsule Storage Delivery
MANUAL CAPSULE FILLING MACHINE
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- Spring '14
- Gelatin, gelatin capsules, soft gelatin capsules, gelatin capsule, hard gelatin, hard gelatin capsule