RESEARCH ON THE DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY OF THE HARD CAPSULES WITH THE DRY FENNEL EXTRACT
DOI:
https://doi.org/10.11603/2312-0967.2022.2.13335Keywords:
fennel dry extract, composition, excipients, technology, biopharmaceutical and pharmacotechnological studiesAbstract
The aim of the work. To develop the composition and technology of the drug in hard gelatine capsules with fennel dry extract for intestinal spasms, flatulence and dyspepsia antispasmodic, carminative, analgesic, anti-inflammatory, antimicrobial and mild diuretic action.
Materials and Methods. Excipients approved for medical use and widely used in pharmaceutical practice were selected during the development of the composition and technology of the drug. Physico-chemical, crystallographic, biopharmaceutical, pharmacotherapeutic research methods were used. Crystallographic studies of fennel dry extract were performed using microscopic analysis on a laboratory microscope “Konus-Academy” (with a magnification 40–60 times) with a built-in video camera Scope Tek. Bulk volume and bulk density were determined on a shaking device model 545-AK-3, flowability – using a funnel with a vibrating device VP-12A.
Results and Discussion. Crystallographic studies of fennel dry extract have shown that it is a polydisperse substance with a lamellar structure and uneven edges and belongs to easily soluble substances. The studied extract is hygroscopic and has unsatisfactory fluidity.
Based on the results of physicochemical, crystallographic, biopharmaceutical and pharmaco-technological studies, the choice of excipients in the mass for encapsulation is substantiated, namely: lactose monohydrate as a filler in the amount of 31 aerosil as a lubricant and moisture regulator in 2 % concentration, microcrystalline cellulose and magnesium stearate as lubricants in the amount of 3.5 and 1.5 %, respectively.
The technology of production of capsules with fennel dry extract and the technological scheme which is the basis of the project of technological regulations for their production were proposed.
Conclusions. The composition and rational technology of the hard capsules with fennel dry extract were experimentally proved and developed based on the conducted pharmaco-technological, physicochemical and biopharmaceutical researches. These capsules can be applied at functional frustration of a digestive tract.
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