The study of the technological and microbiological parameters of a dietary supplement “Osteovert”
Keywords:soft dosage forms, pharmacotechnological parameters, production, extract of harpagophytum, rheumatologic diseases
The main tasks of the treatment of rheumatologic diseases include minimizing pain and inflammation in the joints, as well as restoring their functions. Duration of the treatment and the chronic course of the disease make it difficult to carry out the anti-inflammatory and analgesic therapy, which is characterized by the negative impact of non-steroidal anti-inflammatory drugs (NSAIDs) on an articular cartilage, as well as on organs of the gastrointestinal tract. In this regard, it is important to create new effective and safe products of plant origin, which use involves fewer side effects and the possibility of a longer period of use.
Aim. To study the technological and microbiological parameters of the combined drug – a dietary supplement “Osteovert” in soft gelatin capsules for use in rheumatology and a dry extract of harpagophytum (Harpagophytum procumbens) used in its production.
Materials and methods. The choice of active components in the composition of a dietary supplement “Osteovert” in soft gelatin capsules was substantiated by the analytical review of drugs used in diseases of the musculoskeletal system and presented at the pharmaceutical market of Ukraine, as well as by the results of the own pharmacological studies.
Results and discussion. The research on studying the technological parameters of soft capsules “Osteovert” promoting improvement of the condition of the musculoskeletal system has been conducted. The active ingredients of capsules are glucosamine sulfate, chondroitin sulfate and a dry extract of harpagophytum roots. According to the methods of the State Pharmacopeia of Ukraine (SPhU) the following pharmacotechnological tests of a dry extract have been conducted: the fractional composition, fluidity, which is characterized by determining the angle of repose and the emptying time, the bulk volume and settled volume, settling qualities and density (bulk density and tapped density). In order to develop the specifications of Ukraine for capsules the organoleptic indicators, uniformity of mass for a unit of a dosed drug and disintegration have been determined. The microbiological indicators of intermediate products and capsules “Osteovert” meeting the requirements of the current regulatory documentation have been determined.
The material balance of the batch of capsules “Osteovert” has been calculated.
Conclusions. The pharmacotechnological parameters of a dry extract of harpagophytum have been studied according to the methods of the SPhU. The results of the study were used when substantiating the choice of a dosage form for a dietary supplement “Osteovert”. The manufacturing technology and the flowchart for the manufacturing process of capsules “Osteovert” intended for use in diets as an additional source of glucosamine, chondroitin and harpagoside have been developed. The microbiological quality parameters have been determined for the capsules and the dry extract of harpagophytum obtained. The manufacturing technology for capsules “Osteovert” has been implemented in production at the PJSC “DNCLZ Pilot plant”.
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