We evaluate thestability of the suspensionfor administration to animalsused in carrying outpharmacologicalexperiments.
Under the ordercan be performedvalidationteststhe stabilityof suspensionsfor administration to animalsin terms ofpHof the parameterprecision, in terms ofthe height ofthe supernatantlayerby parameterslinearity andprecision, in terms ofdry residuein the parameterslinearity,accuracy and precision.
According to the National state standard GOST 33044-2014 the Russian Federation standard “The principles of Good Laboratory Practice” the organization has certain rooms for processing of test and standard objects, security compliance storage substances. Disposal of unused test and standard objects in agreement with the customer is carried out at an appropriate landfills with the participation of the environmental state unitary enterprises.
Qualified andexperienced professionalsto provisionalservicesguided bythe requirements of thebasicnormative documentsprovidethe account and safetyof drugs.Control thegoodnessof the objectsat all stages ofthe work. It providesconvenient dosingpatternsanimals.
Functions to provisional service
Acceptance and registration received by the organization of objects, and the accompanying documents
Providestoragefacilitiestaking into account features
Accounting andpuritytestobjects at the stage of preparation and during storage
Preparation of individualdosesto be administeredto experimental animals
Check purityobjects beingprepared forintroduction in the form
Accounting and actionswith unusedobjectsin the experiment
To provisional service provides high quality facilities throughout their time spent at work. During acceptance to provisional service checks the status of incoming objects. It checks the status of the packaging, the appearance of the object itself and the presence of all accompanying documentation. Controlled and mark on each object to properly identify each batch of the objects. Held account of the accompanying documentation to the samples. In obtained from the Customer documentation shall contain information on the storage mode of objects, information on the stability of the object during storage. To provisional service meets the security passports for test and standard objects and informs employees about security measures when dealing with drugs.
According to the OECD and GOST 33044-2014 “Principles of Good Laboratory Practice”, in cases where the test product is provided by Sponsor, shall be submitted to the mechanism, developed in cooperation between the sponsor and the organization conducting pre-clinical trials to establish the authenticity of the objects of research. As should be defined stability test and control facilities for storage, and in the experimental conditions. If the object is inserted as part of the carrier, it is necessary to verify the homogeneity, the stability and concentration of the object in this medium. A sample for analytical purposes from each batch of the test product should be stored. To provisional service developed techniques inspects objects obtained for stability, both during the storage period, and in the course of dissolution and dilution carrier.
After all the procedures to provisional acceptance of service determines the order of storage. When storing objects must respect the identity, the preservation of the concentration, purity and stability, and also provides safe storage for hazardous substances.
For storage to provisional office has allocated storage space with restricted access. The storage room is equipped with racks refrigeration units, for different storage temperatures. The rooms and refrigeration systems is being monitored constantly temperature and humidity/temperature.
On the containers, in which the storage, shall be marked with the specified identification information, expiry date and the storage mode.
Receiving incoming objects, as well as training facilities for the research carried out in the equipped room, separated from the warehouse and on the premises animal. Preparation of the objects of research conducted with the help of an attorney and accurate weighing and measuring equipment.
Before working with the test substances, objects are assigned a unique code. Coding of drugs allows the use of “blind” method of research method in which the employees performing the introduction of objects and receiving data with laboratory animals is not known which of the studied drugs the animal receives. Use a blind method for the analysis of data to reduce errors caused by conscious and unconscious interest of researchers in obtaining certain results of the study. Also, this method allows for a clear and understandable labeling of the objects.
In order to ensure the introduction of laboratory animals of the objects in a convenient form to provisional office carries out the preparation of the dosage. Dosages are prepared extemporaneously (storage time of the preparation of solutions and suspensions do not exceed 4 hours, and in special cases less than 10 minutes prior to administration to an animal).
Unused facilities or returned to the sponsor research or transferred for disposal to a specialized company.
Publications on topic:
Gushina S.V., Makarova M.N., Pozharitskaya O.N. Comparative toxicological studies carriers for medicines used in pre-clinical studies // International Bulletin of Veterinary Medicine. – 2015, №3. – P. 92-98.
Makarenko I.E., Avdeeva O.I., Vanatiev G.V., Rybakova A.V., Khodko S.V., Makarova M.N., Makarov V.G. Possible ways and amounts of drugs administration to laboratory animals // International Bulletin of Veterinary Medicine. – 2013, № 3. – P. 78-84.176.
Karlina M.V., Pozharitskaya O.N., Kosman V.M., Shikov A.N., Zabozlaev A.A., Makarova M.N., Makarov V.G. An in vitro model to evaluate the dissolution rate of the hydrophobic substances of lozenges (lozenges) on the example of coenzyme Q10, in vivo / in vitro correlation // Pharmaceutical Chemistry Journal.– 2012. – T. 46, number 7. C. 52-55.
Guschina S.V., Shapurina S.V., Pozharitskaya O.N., Shikov A.N. Peculiarities of vehicle selection in preclinical study of the plant-based drugs // Abstracts. Phitopharm. 2016. Obzory po klinicheskoj farmacologii i lekarstvennoj terapii. – 2016. – Vol. 14. – P. 22.PECULIARITIES OF VEHICLE SELECTION IN PRECLINICAL STUDY OF THE PLANT-BASED DRUGS
Gushchina SV, Kosman VM, Makarova MN, Shikov ANPreclinical studies of the stability of suspensions prepared from ready-made drugs // Pharmacia.– 2017. – T. 66, No. 3.– P. 27-32.
Kirichenko D.V., Pozharitskaya O.N. Summary influence of auxiliary substances of the solid dosage form on the selection of the carrier for introduction to the laboratory animal // VIII All-Russia Scientific Conference of Students and Postgraduates with International Participants “YOUNG PHARMACY – POTENTIAL OF THE FUTURE”, St. Petersburg, 2018. – Р. 435-337. [Full text is available in Russian].
Kirichenko D.V. The effect of physic-chemical properties of the components of dosage forms on the selection of vehicle for the administration to laboratory animals. Laboratory Animals for Science. – 2020, №2. https://doi.org/10.29296/2618723X-2020-02-09 Abstract. This paper provides the results of the research focused on selection of the carrier of solid dosage forms, which contain components able to form polymer chains. Up to 90% of all dosage forms used as objects for research are solid dosage forms, such as tablets, capsules etc. These are the most popular and common dosage forms. On the other hand, what is comfortable if used by a man can not always be handy in preclinical tests carried out on small laboratory animals. In this paper we list the requirements for carriers, briefly review the excipients which belong to polymers, and suggest an option as how to work with such dosage forms. Based on several medications it is determined that the chemical nature of polymers affects primarily the colloidal properties of suspension which form in contact with water. It is determined that in water the majority of polymers, which are a part of solid dosage forms, form suspension solid to aggregation, which do not need additional stabilization with the help of dispersion phase. It is important to take into account not only the presence of polymers in a specific dosage form, but also the properties of these polymers. Thus, the selection of the carrier of dosage forms, which have polymers as a part either of their active ingredients or of their excipients, requires an integrated approach which should take into consideration the affection of the carrier, used for dosing laboratory animals, on physico-chemical and adsorbing properties of the active ingredients [Full text is available in Russian].
