CRITICAL EQUIPMENT QUALIFICATION PARAMETERS AFFECTING THE HOMOGENIZATION PROCESS OF MEDICAL CANNABIS SEMI-SOLID PHARMACEUTICALS

Abstract

The medical cannabis has been used for many of years for medicinal purpose, in different pharmaceuticalformulation, mostly as a magistral preparation for the relief of pain in cancer patients or chronical painful diseases.Over than 540 substances were found from which more than 100 that have been found to be cannabinoids due totheir similar chemical structure. The component with the most psychotropic action is Δ9 -tetrahydrocannabinol (Δ9 -THC), and the major non-psychoactive ingredient is cannabidiol (CBD). Δ9 -tetrahydrocannabinol firstly wasisolated in 1969 by Robert Mechoulm and Yechiel Gaoni. In 2003 World Health Organization put Δ9 -tetrahydrocannabinol in Schedule IV of the convention. Several therapeutic indications relate to the Δ9 -THC andCBD as analgesia, inflammatory and neurodegenerative diseases, and many other cases. In some studies, there arereported safety concerns about the registered side effects of Δ9 - THC as a psychoactive. For that reason, the legalusage of cannabis for medicinal purposes and for recreational use is regulated differently. The most relevantexplanation is related to the not enough sufficient results and data obtained from the pharmacokinetic studies andresearch in pharmacological behavior. Extracts of cannabis was used from many years ago. Nowadays inpharmaceutical industry as the development of technology there are many dosage forms in where extracts,cannabinoids, flower are used. Medicinal cannabis products can come in many different forms, including capsules,drops, chewable, creams, crystals, flower, lozenges, oil (most common), oro-mucosal sprays, tinctures and manymore. Also, there are synthetic analogs to nature cannabinoids in pharmaceutical market. In this study will bediscussed about production of semisolid pharmaceutical forms obtained from medical cannabis. They are producedin pharmaceutical grade equipment, high-pressure homogenizer mixer. In this study it will be discussed about theprocess of equipment qualification. Firstly, by the user requirement specification, design qualification protocol wasapproved. Then factory acceptance test was performed in production site of equipment and site acceptance test wasperformed in costumer’s site. Then installation qualification protocol was look through and then operationalqualification protocol also. All the qualification protocols were approved by both sides. In different qualificationprotocols, different tests were performed, and they are explained separately. During the qualification process, thereare considered some of the parameters which later during the production process can affect in the quality of finishedproducts. These parameters are called critical process parameters and accent will be put on this process parametersthat are with a critical effect on quality of the final products. This critical process parameters were considered andconcluded from qualification protocols where all the parameters that can affect quality of the product wereseparately examine.