Critical equipment qualification parameters affecting the homogenization process of medical cannabis semi-solid pharmaceuticals

The medical cannabis has been used for many of years for medicinal purpose, in different pharmaceutical formulation, 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 to their 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 was isolated 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 and CBD as analgesia, inflammatory and neurodegenerative diseases, and many other cases. In some studies, there are reported safety concerns about the registered side effects of Δ9 -THC as a psychoactive. For that reason, the legal usage of cannabis for medicinal purposes and for recreational use is regulated differently. The most relevant explanation isrelated to the not enough sufficient results and data obtained from the pharmacokinetic studies and research in pharmacological behavior. Extracts of cannabis was used from many years ago. Nowadays in pharmaceutical 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 many more. Also, there are synthetic analogs to nature cannabinoids in pharmaceutical market. In this study will be discussed about production of semisolid pharmaceutical forms obtained from medical cannabis. They are produced in pharmaceutical grade equipment, high-pressure homogenizer mixer. In this study it will be discussed about the process of equipment qualification. Firstly, by the user requirement specification, design qualification protocol was approved. Then factory acceptance test was performed in production site of equipment and site acceptance test was performed in costumer’s site. Then installation qualification protocol was look through and then operational qualification protocol also. All the qualification protocols were approvedby both sides. In different qualification protocols, different tests were performed, and they are explained separately. During the qualification process,there are considered some of the parameters which later during the production process can affect in the quality of finished products. These parameters are called critical process parameters and accent will be put on this process parameters that are with a critical effect on quality of the final products. This critical process parameters were considered and concluded from qualification protocols where all the parameters that can affect quality of the product were separately examine

Хербални дроги во третман на варикозни вени

Варикозните вени и венската инсуфициенција на долните екстремитети се едни од најчестите заболувања кои особено ја афектираат повозрасната популација. Оваа состојба се одликува со издолжување, проширување и извиткување на вените, а најчесто се јавува во нозете. Варикозните вени се голем проблем со кој се соочува 10-20% од популацијата. Инциденцата на појава се зголемува со годините и тоа најчесто кај луѓе постари од 50 години,со четири пати поголема застапеност кај жени отколку кај мажи. Хербалните препарати како третман и превенција на варикозните вени треба да делуваат на следниот начин: Васкуларен тонус - Се подобрува тонусот и цврстината на венските садови. Хербалните препарати кои се богати со флавоноиди се посебно индицирани при подобрување на тонусот. Циркулаторни стимуланси -Помагаат при процесот на враќање на крвта од вените кон белодробието. Адстригенти-Го подобруваат васкуларниот тонус и се аплицираат екстерно (на кожата). Антиинфламатори - Ја намалуваат локалната инфламација. Емолиенти - Нанесени екстерно ја намалуваат локалната инфламација.Хербалните препарати кои се богати со флавоноиди имаат главна улога при зголемување на тонусот на венските ѕидови при венска инсуфициенција. Притоа, најчесто употребувана дрога е семето од Aesculus hipocastanum L., -див костен

Development and optimization of the process of decarboxylation of tetrahydrocannabinoic acid, followed by FTIR detection of tetrahydrocannabinol in medicinal Cannabis

Aim of the study: Conversion of tetrahydrocanabinoic acid (THCA) to tetrahydrocannabinol (THC), is the main reaction essential for the use of cannabis,Cannabis indica L. buds in medicinal purposes. Therefore, the aim of this study was to develop and optimize the thermal treatment of Cannabis buds, required for the reaction of decarboxylation of THCA to THC followed by FTIR technique. Materials and methods: Cannabis buds were heated on aluminum shelves,programmed by heating oven POL EKO SL 400. Temperature program was strictly monitored and changes were recorded on every 5 minutes. Mid Infrared spectra were collected for each sample and temperature, respectively, using Perkin Elmer Spectrum Two™ coupled to an UATR accessory in spectral range of 400-4000 cm-1. Results: Changes in the infrared spectra indicated that the required elimination of water and appropriate conversion of THCA to THC were established, as the reaction progressed. Reaction of decarboxylation has occurred in temperature range from 85-120° C. Conversion of THCA to THC contributed for obtaining of high concentrations of THC which ranged 38-80% w/w. The progress of the decarboxylation enhanced the obtaining of THC. Conclusion: Monitoring of the process of decarboxylation with FTIR technique presents a fast and plausible method for controlling the conversion of acidic forms of cannabinoids to their neutral forms. The thermal treatment has shown a high yield of THC up to 80% w/w. It should be stressed out that these two methods could be ideally suited to everyday analysis because of their high performances