Scientific Center for Expertise of Medical Products

Petrovskiy, Russia

Scientific Center for Expertise of Medical Products

Petrovskiy, Russia
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Shohin I.E.,Moscow Medical Academy | Ramenskaya G.V.,Moscow Medical Academy | Vasilenko G.F.,Scientific Center for Expertise of Medical Products | Malashenko E.A.,Moscow Medical Academy
Dissolution Technologies | Year: 2010

The current paper is devoted to in vitro dissolution kinetics studies of amlodipine tablets marketed in Russia under biowaiver conditions. Dissolution kinetics studies were carried out according to WHO Guidance. Dissolution profiles of test and reference (innovator) amlodipine tablets were considered equivalent.


Matveeva O.A.,Scientific Center for Expertise of Medical Products | Kovaleva E.L.,Scientific Center for Expertise of Medical Products
Pharmaceutical Chemistry Journal | Year: 2016

This review considered international approaches to assessment of the content of genotoxic impurities (residual solvents and various inorganic and organic impurities) in drugs. Foreign and domestic regulations defining requirements for the classification, control, and toxicological risk assessment of potential genotoxic impurities in drug substances and drugs were compared. The use of highly sensitive and specific analytical methods for detecting genotoxic impurities in drugs was justified. The need to improve the domestic regulatory framework on the control of elemental genotoxic impurities (heavy metals) and to prepare guidelines on the assessment of potentially genotoxic organic impurities in drugs was demonstrated. © 2016, Springer Science+Business Media New York.


Shohin I.E.,Moscow State University | Kulinich J.I.,Moscow State University | Ramenskaya G.V.,Moscow State University | Vasilenko G.F.,Scientific Center for Expertise of Medical Products
Dissolution Technologies | Year: 2011

This paper describes the evaluation of the in vitro equivalence of capsules containing a BCS Class II compound, ketoprofen, marketed in Russia under biowaiver conditions and the innovator product. The in vitro equivalence test was carried out according to WHO Technical Report Series, No. 937, Annex 8. Dissolution profiles of test and reference (innovator) ketoprofen capsules are considered equivalent at pH 6.8 without statistical treatment, equivalent at pH 4.5 (f1 = 3 and f1 = 80), and not equivalent at pH 1.2 (f1 = 22 and f2 = 41). Generally, the evaluated capsules did not meet biowaiver criteria for drugs containing BCS Class II API, possibly due to the effect of surfactant (sodium lauryl sulfate) contained in the test preparation on the solubility.


Gunar O.V.,Scientific Center for Expertise of Medical Products | Builova I.A.,Scientific Center for Expertise of Medical Products
Pharmaceutical Chemistry Journal | Year: 2016

A new approach to microbiological analysis of several pharmaceuticals, in particular, those that can be used in manufacturing sterile medical products, is presented. The proposed approach was verified using a series of 23 samples of various products, three of which were obtained by biotechnological methods. The scheme includes inoculation of samples with test strains followed by isolation and analysis of the contaminants. Validation results showed that the amount of products for microbiological analysis could be reduced to 3 g, which was sufficient for obtaining reliable results. Tryptic soy broth was used as the solvent (diluent) and enrichment broth for microbe growth. © 2016, Springer Science+Business Media New York.


Shohin I.E.,Moscow State University | Kulinich J.I.,Moscow State University | Vasilenko G.F.,Scientific Center for Expertise of Medical Products | Ramenskaya G.V.,Moscow State University
Indian Journal of Pharmaceutical Sciences | Year: 2011

The WHO biowaiver procedure for BCS Class II weak acids was evaluated by running two multisource IR ibuprofen drug products (Ibuprofen, 200 mg tablets, Tatchempharmpreparaty, Russia and Ibuprofen, 200 mg tablets, Biosintez, Russia) with current Marketing Authorizations (i.e. in vivo bioequivalent) through that procedure. Risks associated with excipients interaction and therapeutic index were considered to be not critical. In vitro dissolution kinetic studies were carried out according WHO Guidance (WHO Technical Report Series, No. 937, Annexes 7 and 8) using USP Apparatus II (paddle method) at 75 rpm. Dissolution profiles of test and reference ibuprofen tablets were considered equivalent in pH 4.5 using factors f 1 (13) and f 2 (72) and not equivalent in pH 6.8 (factor f 1 was 26 and f 2 was 24). Drug release of ibuprofen at pH 1.2 was negligible due to its weak acid properties. Therefore, two in vivo bioequivalent tablets were declared bioinequivalent by this procedure, indicating that procedure seems to be over-discriminatory.


Merkulov V.A.,Scientific Center for Expertise of Medical Products | Sakanyan E.I.,Scientific Center for Expertise of Medical Products | Klimov V.I.,Scientific Center for Expertise of Medical Products | Shemeryankina T.B.,Scientific Center for Expertise of Medical Products | And 2 more authors.
Pharmaceutical Chemistry Journal | Year: 2016

Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization system in the Russian Federation, which includes drug substances, requires revision for the creation and attestation of national reference standards, including pharmacopoeial ones. © 2016, Springer Science+Business Media New York.


Volkova E.A.,Moscow State University | Ramenskaya G.V.,Moscow State University | Shohin I.E.,Moscow State University | Vasilenko G.F.,Scientific Center for Expertise of Medical Products | Savchenko A.Y.,Scientific Center for Biomedical Technologies
Russian Journal of Biopharmaceuticals | Year: 2011

The article is devoted to dissolution kinetics studies of preparations containing low-soluble substance (nifedipine) in biorelevant media (media modeling physiological gastrointestinal conditions). Dissolution profiles of two nifedipine IR drug products in fasted state simulate intestinal fluid (FaSSIF), and sodium lauryl sulphate solutions (0.05 and 0.1 %) are provided. It was shown that 0.05 % sodium lauryl sulphate solution provides the same dissolution rate and discriminatory power as FaSSIF, and could be used as low-cost alternative.


Kuz'mina N.E.,Scientific Center for Expertise of Medical Products | Moiseev S.V.,Scientific Center for Expertise of Medical Products | Krylov V.I.,Scientific Center for Expertise of Medical Products | Yashkir V.A.,Scientific Center for Expertise of Medical Products | Merkulov V.A.,Scientific Center for Expertise of Medical Products
Journal of Analytical Chemistry | Year: 2015

A correlation equation is obtained for the evaluation of the average molecular weight (MW) of hydroxyethyl starches from the self-diffusion coefficient D measured using diffusion-ordered NMR spectroscopy. Correlation equations MW = cD−αare compared for hydroxyethyl starches, dextrans, and pullulans. It has been demonstrated that different MWs correspond to constant D values of uncharged polysaccharides with the similar type of nonvalent interactions and different degrees of branching. © 2015, Pleiades Publishing, Ltd.


Ramenskaya G.V.,Moscow State University | Shohin I.E.,Moscow State University | Savchenko A.Y.,Scientific Center for Expertise of Medical Products | Volkova E.A.,Moscow State University
Biomeditsinskaya Khimiya | Year: 2011

The review deals with the modern tool for modeling of drug behavior in vivo, - the dissolution test in biorelevant media, imitating gastrointestinal fluids. The formulations and preparation methods of fasted state simulation intestinal fluid, FaSSIF and fed state simulation intestinal fluid, FeSSIF, are defined. In addition, the dissolution characteristics of APIs from different BCS classes in biorelevant media are described. Possible applications of biorelevant media in regulatory practice and science are also shown.


Gavrishina E.V.,Scientific Center for Expertise of Medical Products | Dobrovolskii A.V.,Scientific Center for Expertise of Medical Products | Niyazov R.R.,Scientific Center for Expertise of Medical Products | Romodanovskii D.P.,Scientific Center for Expertise of Medical Products | Vasil'ev A.N.,Scientific Center for Expertise of Medical Products
Eksperimental'naya i Klinicheskaya Farmakologiya | Year: 2015

General principles of appropriate strategies for preclinical and clinical development of unfractionated and low-molecular-weight heparins and demonstration of their biosimilarity to corresponding reference medicinal products are provided. Demonstration of the biosimilarity of heparin-containing medicinal products constitutes the basis for their efficacy and safety during anticoagulation therapy. Hie main quality, safety, and efficacy characteristics of heparin products are described and the extent of non-clinical and clinical investigations necessary prior to drug marketing authorization are considered.

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