Strilets O. The scientific and experimental justification of the technology and the composition of the combined tablet forms with antihypertensive effect

Українська версія

Thesis for the degree of Doctor of Science (DSc)

State registration number

0513U001270

Applicant for

Specialization

  • 15.00.01 - Технологія ліків, організація фармацевтичної справи та судова фармація

05-12-2013

Specialized Academic Board

Д 64.605.02

National University of Pharmacy

Essay

The dissertation is devoted to the development of scientific-methodical march to the creation of combined drugs with active ingredients from different pharmacological groups (?- blocker - bisoprolol fumarate, an ACE inhibitor - lisinopril dihydrate , calcium channel blocker - amlodipine besylate , a diuretic - indapamide) in the form of tablets. The complex of theoretical and experimental studies on the pharmakotechnological and physico-chemical properties of active substances and excipients were conducted. The effect of the auxiliary components for process parameters and indicators of quality of pills was studied. On the basis of technological, biopharmaceutical and pharmacological tests formulations were developed, industrial technology of tablets codenamed "Amlopamid" and "Bisopamid " by direct compression was justified. According to the results of the complex physical and chemical, pharmakotechnological, biological research projects production schedules and documents "Methods of quality control on the drug" were developed. The parameters of quality control, which are included in the standard documentation, were suggested. The conditions and terms of storage products were defined. The specific activity designed tablets was set with preclinical trials. It is to antihypertensive, antiarrhythmic, diuretic action, by combining different mechanisms to reduce blood pressure, which provides a number of advantages over monotherapy unconditional. Pharmacological studies identified no acute toxicity, irritant and allergic effects.

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