Capsule Machine Validation

Abstract

Instrumentation has become an integral function for any compounding operation, particularly for hard-gelatin capsules. This study examined the use of a capsule machine in a simulated compounding operation. It is an instrument that is reasonably priced and can deliver 24 capsules within ten minutes of operation. Capsule Connection LLC suggests the use of this machine for filling capsules with herbal or vitamin preparations. Moreover, this instrument may be used for training pharmacy students in a pharmaceutics/compounding laboratory. The main objective of the research was to calibrate and validate a capsule formulation for acetaminophen using the Capsule Machine from Capsule Connection LLC. Twenty Capsule Machines were purchased from Capsule Connection LLC. The machines were first calibrated and then validated using spray-dried lactose monohydrate powder. Based on the results obtained from the calibration and validation process, a powder mixture containing acetaminophen was prepared by mixing acetaminophen with lactose in a glass mortar using the geometric dilution method. The labeled amount of acetaminophen per capsule was 81 mg. Capsules generated from this compounding operation were tested using the United States Pharmacopeia content uniformity test. The calibration and validation processes were repeated twice with lactose monohydrate. The overall average weights for size-0 capsule shells and lactose-filled capsules were 94.61 mg and 545.77 mg, respectively. On average, the content of a capsule was estimated to be 451.16 mg of powder. A powder mixture was prepared to make 480 capsules (20 machines, each producing 24 capsules). This mixture was made of 38.88 g of acetaminophen and 177.68 g of lactose. A 3% amount of additional powder was added to account for the powder loss during the operation. All capsule machines passed the United States Pharmacopeia content uniformity test. The average amount of acetaminophen per capsule was 98.91% of the labeled amount. Only less than 5% of the capsules were lost during the filling operation of lactose in capsules and none lost with the acetaminophen capsules. The Capsule Machine from Capsule Connection LLC produced capsules containing acetaminophen with high reproducibility and accuracy.