The technology development for the complex Api-phyto product "Apised" in the form of capsules with the restorative and sedative action

• Main Authors: O. S. Shpychak (Author), O. I. Tikhonov (Author), V. M. Koval (Author), S. G. Bobro (Author), A. O. Shpychak (Author)
• Format: Book
• Published: Zaporozhye State Medical University, 2017-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 10.14739/2409-2932.2017.3.113645; 2306-8094; 2409-2932
• Keywords: honey; medicinal plant raw material; "Apised" capsules; sedatives; sports medicine; Pharmacy and materia medica; RS1-441
• Source: Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki, Iss 3, Pp 355-363 (2017)

The aim of the study is to substantiate and experimentally develop the technology for the complex api-phyto product "Apised" (which is used to treat nervous disorders and the psycho-emotional stress in extreme conditions, in particular in sports medicine) in the form of gelatin capsules in pharmacy conditions and in conditions of industrial production based on the pharmaceutical-technological and physical-chemical studies. Materials and methods. As the research objects the experimental samples of "Apised" capsules, as well as their mixtures of masses for encapsulation were used. These mixtures contain such active pharmaceutical ingredients (API) as a standardized substance of powdered honey (PH), medicinal plant raw material (Melissa herb, hop cones, true lavender flowers) and the following excipients (antifriction substances): aerosil (anhydrous colloidal silicon dioxide) or the mixture of aerosil and calcium stearate (3:1) in the amount of 2 %, as well as a wetting agent - 5 % solution of Plasdone K29/32. Results. The obtained results of the experimental studies were used when developing the flowcharts of the manufacturing process for "Apised" capsules in pharmacy conditions and in conditions of the standard operating procedure for the drug. Taking into account the physical-chemical properties of API included in the composition of the drug the flowchart of the manufacturing process for the complex api-phyto product in conditions of industrial production and the project of the specification were developed, the technological parameters of its manufacturing were substantiated, the optimal amount of excipients and a wetting agent required for performing the proper technological process was calculated, as well as the control over the sequence of mixing of active substances and excipients, moisturizing and obtaining of wet granules, drying and sizing of granules, obtaining of the encapsulated mass and other control parameters affecting the quality and stability of the drug were conducted. The technology for "Apised" capsules was tested in pharmacy and industrial conditions. Conclusions. The technology for "Apised" capsules has been theoretically substantiated and experimentally developed. The flowcharts for their manufacturing process in pharmacy conditions and in conditions of industrial production have been developed. The results of the experiment were used when developing the projects of the standard operating procedure and the specification for the drug under research. The technology has been tested in pharmacy and industrial conditions.