IMPROVEMENT OF THE COMPOSITION AND DEVELOPMENT OF THE EXTEMPORANEOUS TECHNOLOGY OF PESSARIES WITH DOXYCYCLINE HYCLATE BASED ON COCOA BUTTER
DOI:
https://doi.org/10.11603/2312-0967.2020.1.10979Keywords:
pessaries, composition, doxycycline hyclate, cocoa butter, extemporaneous technologyAbstract
The aim of the work. To improve the composition and develop of the extemporaneous technology of pessaries with doxycycline hyclate based on cocoa butter.
Materials and Methods. Extemporaneous prescriptions for the treatment of vaginal infections have been found to be often represented by polyethylene oxide-based pessaries with doxycycline hyclate. In order to improve them, in addition to doxycycline hyclate, liniment of syntomycin, dimexide and menthol were introduced in their composition. The cocoa butter mixture with beeswax was used as suppository base. The preparation of the pessaries was performed by the method of pouring out, taking into account the requirements of the State Pharmacopoeia of Ukraine 2.0 and the Instruction of the Ministry of Health of Ukraine “Requirements for the preparation of non-sterile medicines in the conditions of pharmacies”. To determine the pharmacotechnological parameters of model samples of the medicine, their description (homogeneity), melting point and resistance to destruction were studied.
Results and Discussion. To determine the optimal ratio of cocoa butter and beeswax in the composition of the suppository base, the pharmacotechnological parameters of their model samples were investigated. Components ratios 92.5:7.5 and 95.0:5.0 were selected for further studies. When studying the effect of emulsifiers (emulsifier T-2, lecithin) on some indicators of the quality of pessaries, it was found that only samples of the medicine on the selected suppository base in the ratio of 95.0:5.0 with a content of lecithin in the amount of 2-3 % meet the requirements of SPU in terms of “Description” and “Melting point”.
It has been experimentally proven that doxycycline hyclate is mixable with the liniment of syntomycin and glycerol, which promotes its even distribution in the suppository base and improves the quality of pessaries (no sedimentation effect).
In the development of extemporaneous technology of the medicine by the method of pouring is determined the inverse coefficient of substitution of doxycycline hyclate in cocoa butter, which is 0.81. The samples of the pessaries prepared according to the proposed technology were analyzed according to the quality indicators in accordance with the requirements of SPU 2.0, current orders, instructions and guidelines of the Ministry of Health of Ukraine.
Conclusions. Experimental studies have been conducted to improve the composition of extemporaneous pessaries with doxycycline hyclate for the treatment of infectious vaginitis. In addition to doxycycline hyclate, the liniment of syntomycin, dimexide and menthol was introduced into the medicine. As a suppository base used a mixture of cocoa butter and beeswax in a ratio of 95.0:5.0. Extemporaneous technology of pessaries by pouring method has been developed. It is shown that the obtained samples of pessaries fully meet the requirements of the SPU to this dosage form.
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