Biopharmaceutical substantiation of the composition and analysis of the soft dosage form with chloropyramine hydrochloride


A.A. Chakhirova(1), E.V. Kovtun(1), V.A. Chakhirova(1), N.V. Blagorazumnaya(1), D.O. Bokov(2, 3), A.A. Prokopov(4), I.A. Samylina(2)
1-Pyatigorsk Medical and Pharmaceutical Institute – branchof theVolgograd State Medical University of the Ministry of Health of Russia, Kalinina Ave., 11, Pyatigorsk, 357532, Russian Federation;
2-A.P. Nelyubin Institute of Pharmacy, Sechenov First Moscow State Medical University, st. Trubetskaya, 8, building 2, Moscow, 119991, Russian Federation;
3-Federal State Budgetary Scientific Institution “Federal Research Center of Nutrition and Biotechnology”, Ustinsky proezd, 2/14, Moscow, 109240, Russian Federation;
4-Department of General and Bioorganic Chemistry, Moscow State Medical and Dental University named after A.I. Evdokimov, st. Delegatskaya, 20, building 1, Moscow, 127473, Russian Federation

Introduction. An urgent task of our time is the search for new dosage forms for already known and widely used active substances. An example is suprastin, which is used to treat allergic diseases that cause inflammatory processes: dermatoses, angioedema, urticaria, allergic rhinitis, initial manifestations of bronchial asthma and is usually prescribed orally in the form of tablets or solutions. However, these routes of administration have a number of disadvantages, which are easily mitigated in soft dosage forms. Ease of administration, good bioavailability, the possibility of systemic action of drugs and the speed of its development, active absorption of substances that undergo breakdown in the gastrointestinal tract. Considering the advantages of the ointment as a dosage form, and the data on the pharmacological effectiveness of suprastin, it seems appropriate to develop a soft dosage form with pronounced anti-inflammatory and antihistamine activity and methods for qualitative and quantitative determination of the active substance. Purpose. Conduct biopharmaceutical research on the selection of a base for a soft dosage form with chloropyramine hydrochloride. To determine the optimal conditions for the spectrophotometric determination of chloropyramine hydrochloride, which is part of the dosage form. Material and methods. The object of the study was ointment compositions, which included chloropyramine hydrochloride 0.1 g. When choosing the optimal conditions for confirming the authenticity of chloropyramine hydrochloride in the ointment, a model mixture was prepared with the exact content of all components. The CO spectra of chloropyramine hydrochloride and its extract from the ointment in water, solutions of sodium hydroxide and hydrochloric acid were recorded using an SF-56 spectrophotometer in the wavelength range from 220 to 350 nm. Results. 5 ointment compositions with suprastin are proposed. Based on biopharmaceutical studies, the degree of release of the active substance was studied. To confirm the authenticity of the soft dosage form, the absorption spectra of chloropyramine hydrochloride in three solvents were used – purified water, 0.1 M sodium hydroxide solution and 0.1 M hydrochloric acid solution. The absorption spectrum in a 0.1 M solution of hydrochloric acid has more pronounced maxima and stable optical density. Conclusion. The greatest release of the active complex occurs from the hydrophilic base, which can serve as a basis for its use in the production of soft dosage forms with suprastin. Methods have been developed to confirm the authenticity of chloropyramine hydrochloride in soft dosage form. The possibility of using spectrophotometry to identify the studied medicinal substance in the ointment has been demonstrated.

soft dosage forms
biopharmaceutical research
hydrophilic bases
maximum absorption.

  1. Reken M., Schaller M., Sattler E., Burgdorf W. Atlas of dermatology. M: Medexpress-inform, 2012; 166, 194, 196 (in Russian).
  2. Pertsev I.M., Datsenko B.M., Gunko V.G. Multicomponent ointments on a hydrophilic basis. Pharmacy. 1990. 39 (4): 73–7 (in Russian).
  3. Kostina A.A. Biopharmaceutical research on the selection of auxiliary components for the gel with Leuzea extract. Pharmacy and pharmacology. 2017; 3 (4): 3–6 (in Russian).
  4. Kovtun E.V. Biopharmaceutical research as a way to select excipients for intranasal dosage forms. In the collection: SCIENCE AND TECHNOLOGY RESEARCH (2023). Collection of articles of the International Scientific and Practical Conference. Petrozavodsk, 2023; 121–5 (in Russian).
  5. Tsuprikov P.V., Kazerskaya A.A. In the collection: product quality: control, management, improvement, planning. collection of scientific papers of the 3rd international youth scientific and practical conference: in 2 volumes. 2016; 319–22 (in Russian).
  6. Ganicheva L.M., Vdovina G.P. Biopharmaceutical aspects of the development, production and use of drugs. Vestn. Volgograd. state honey. un-ta. 2012; 3 (43): 3–9 (in Russian).
  7. Gammel I.V., Zhukova O.V., Kononova S.V., Konnova M.A. Study of the range of medicines in ointment dosage form. Questions of biological, medical and pharmaceutical chemistry. 2019; 22 (8): 3–9 (in Russian).