Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Capsule Machine Validation

Author(s):  Al-Achi Antoine, McGreggor Tysheon, Jaligama Shreelekha, Friday Kafi, Alyami Hussain

Issue:  Jan/Feb 2022 - Volume 26, Number 1
View All Articles in Issue

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.

Related Keywords: Antoine Al-Achi, PhD, Tysheon McGreggor, MS, Shreelakha Jaligama, MS, Kafi Friday, BS, Hussain Alyami, BS, manual capsule filling machine, USP content uniformity test, hard gelatin capsules, United States Pharmacopeia, calibration, acceptance value, actual capability index

Related Categories: PEER-REVIEWED, TECHNOLOGY, QUALITY CONTROL

Printer-Friendly Version




Download in electronic PDF format for $55

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Capsule Machine Validation Al-Achi Antoine, McGreggor Tysheon, Jaligama Shreelekha, Friday Kafi, Alyami Hussain Jan/Feb 2022 58-64 Buy
Accuracy Considerations in Sterile Compounding Akers Michael J Mar/Apr 2017 133-142 Buy
The Basics of Compounding: Compounding Special Capsules Allen Loyd V Jr Jul/Aug 1999 291-294 Buy
Pharmaceutical Development of Enteric-Release Hard Gelatin Capsules in the Compounding Setting de Oliveira Ferreira Anderson, Holandino Carla Mar/Apr 2008 163-169 Buy
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1 Allen Loyd V Jr Mar/Apr 2020 92 Buy
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2 Allen Loyd V Jr May/Jun 2020 180 Buy
Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice Kelley Brian Mar/Apr 2021 115-124 Buy
Basics of Compounding: Special Capsules Allen Loyd V Jr May/Jun 2016 209-214 Buy
Technology Spotlight: Capsule-Filling Machines Allen Loyd V Jr Jan/Feb 2002 31 Buy
Quality-Control Analytical Methods: Determination of Tapped Bulk Volume for Compounded Prescriptions Al-Achi Antoine, Siddoju Srujana May/Jun 2005 207 Buy