By 2022, SID & GP will have developed several pediatric dosage forms
In Kazan, the 1st All-Russia Pharmaceutical Car Race dedicated to the topic «National objectives in healthcare. The development issues of priority» was started. The event was opened with a round-table discussion «Effective mechanisms of drug provision in the Russian Federation. The issues of quality and availability across regions», where one of the key points was dedicated to pediatric medicines.
In the capital of Tatarstan, the 1st pharmaceutical car race was started to join regulators and drug manufacturers, pharmacy chains and consumers. The pharmaceutical car race is not just a grand-scale initiative, but also a very busy agenda in the cities the participants’ car columns will go by. Thus, this day in Kazan, at the round-table discussion “Effective mechanisms of drug provision in the Russian Federation. The issues of quality and availability across regions”, the effective mechanisms of drug provision, the issues of availability and quality of medicines, unclouding pediatric ones, in regions were discussed.
As emphasized by the Director of SID & GP Mr. Vladislav Shestakov, the laboratories of the Institute are today implementing the program of developing suppositories. The program is estimated to last until 2022 and includes not only a search for next-generation compounds having curative properties, but also carrying-out of pre-clinical and clinical trials of the various dosage forms developed by SID & GP by the Pirogov Russian National Research Medical University which has indeed transferred to R&D subdivisions of SID & GP 2 pediatric dosage forms. «Based on the results of these trials, having confirmed therapeutic efficacy and safety of medicines developed by us, we will look for partners pursuing commercialization of medicines which are of utmost importance for our children,» Mr. Vladislav Shestakov said.
What are these dosage forms?
In 2019-2020, the R&D center of SID & GP will be developing semi-solid dosage forms with immune-modulating properties and will be preparing relevant quality control methods followed by their validation and MM drafting. Besides, the center will be developing the semi-solid dosage form of the relaxing effect followed by manufacture of primary batches.
In 2020-2021, the laboratories will start developing the pediatric semi-solid dosage form of the antipyretic and relaxing effect, as well as the dosage form of the antihistamine effect.
At the closing stage (2021-2022), the Institute’s subdivision will be developing dosage forms of the diuretic and cardio-vascular effect.
As a reminder, starting from 2018, the program «The Decade of Childhood» has been being implemented in Russia, which includes, among other things, development and provision of drugs for perhaps the most fastidious consumers. SID & GP has become involved in these activities for the reason that, apart from execution of the functions of inspecting foreign drug manufacturers for GMP compliance, historically the R&D stream has been quite on a high level in the Institute.
«Without reaching back to the history, I will focus on the fact that initially, in 1973, our structure, although bearing a different name, was founded with the aim to develop and master the technology of manufacture of novel blood substitutes and hormonal preparations, as well as for improvement of their manufacturing technologies at facilities. And the today’s R&D subdivision is worthily taking up this business working on development and pilot release of trial samples of innovative medicines. By the way, very soon our laboratories will move to a state-of-the-art facility equipped with advanced analytical and testing equipment, as well as process equipment, which will allow us to develop even more drugs, including pediatric dosage forms,» the Director of SID & GP commented.
- The Director of SID & GP opened a new manufacturing site in Nizino
- Export potential of Russian pharmaceuticals has been discussed at the SPIEF
- Good practices in drug quality assurance from development to the consumer
- GMP inspectorates of Russia and Uzbekistan signed an Agreement on Cooperation
- Typical PQS deficiencies found at drug manufacturers: what does a GMP inspection focus on?