Abstract
Objective: Development of a rational composition, optimal technology, standardization criteria for tablets with Rheum cordatum extract, establishing the stability of the composition and storage conditions. Methods: As an active pharmaceutical substance, a standardized extract of Rheum cordatum was used. Pharmacopoeial excipients for the production of tablet mass are magnesium hydroxycarbonate, croscarmellose sodium, microcrystalline cellulose, Plasdone S-630, magnesium aluminum metasilicate, calcium stearate, purified water and film coating Opadry 85F18422 White. To obtain tablets qualified equipment was used in the technological process: a tablet mass mixer, a rotary tablet press, highly efficient film coating equipment, a packaging machine / blister machine. When developing the tablets, we were guided by the «Quality by design» concept of medicines, based on ICH guidelines: ICH Q11 «Development and manufacture of medicinal substances», ICH Q8 «Pharmaceutical Development» and ICH Q10 «Pharmaceutical Quality System». Standard pharmacopoeial research methods were used. Results: 50 experimental mass models for tableting have been developed in the variants of combining excipients and active substance in an effective single dose of 300 mg. Only 4 models of the core tablets obtained met the selection criteria (abrasion, crush resistance, disintegration, and dissolution). The optimal tableting method using wet granulation is substantiated, which makes it possible to obtain tablets of the proper pharmacopoeial quality and the following composition: soft rhubarb root extract, magnesium hydroxycarbonate, croscarmellose sodium, microcrystalline cellulose 102, Plasdone S-630, magnesium aluminum metasilicate, calcium stearate. To coat the obtained tablet cores, the following film coating composition was selected: Opadry 85F18422 White, consisting of polyvinyl alcohol, titanium dioxide E 171, macrogol 4000 and talc. Conclusions: The pharmaceutical development of coated tablets with an extract of Rheum cordatum has been done. The rational composition and optimal technology for producing tablet cores coated with a film coating of Opadry 85F18422 White were established. The quality of the obtained tablets was evaluated, the stability of the composition for 9 months was studied, the results of quality indicators are within acceptable standards, and research in this direction is going on. Keywords: Extract, coated tablets, pharmaceutical development, composition, technology, stability.
Highlights
IntroductionThe creation of new import-substituting drugs of domestic production is one of the most important tasks of the pharmaceutical industry of Kazakhstan
In accordance with the functional characteristics and technological purpose, pharmacopoeial-quality magnesium-hydroxycarbonate (DMV Fonterra, Germany), croscarmellose sodium (Roquette, France), microcrystalline cellulose (JRS Pharma, Germany), Plasdone S-630 (Ashland, USA), magnesium aluminometasilicate (Fuji Chemical Industries, Japan), calcium stearate (Peter Greven, Germany), film coating Opadry 85F18422 White (Colorcon) and purified water were used as excipients for the preparation of the tablet mass
In the experiment we studied tablet models using auxiliary substances in various combinations, with the active substance content in an effective dose of 300 mg in one tablet
Summary
The creation of new import-substituting drugs of domestic production is one of the most important tasks of the pharmaceutical industry of Kazakhstan. In this regard, the study of domestic types of medicinal plant materials and their processing, the creation of medicines based on them and their introduction into medical practice is relevant. Of particular interest are plants of the genus Rhubarb (Rheum L.) of the Polygonaceae family, which are a valuable source of biologically active substances and widely used in official and traditional medicine. The pharmacological action of plants of the genus Rhubarb (Rheum L.) is due to the sum of biologically active substances, such as anthracene derivatives, flavonoids in the form of glycosides and aglycones, tannins, etc. It is known that plants of the genus Rheum L. possess a laxative, antioxidant, anti-inflammatory, antitumor, antimicrobial, antifungal, antiulcer, analgesic and hepatoprotective effect [5-9].
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