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Journal №11 for 2013 г.
Article in number:
Drug-excipient compatibility studies by differential scanning calorimetry
Authors:
N.A. Polyakov - Ph.D., Leading Research, All-Russian Scientific Research Institution for Medicinal and Aromatic Plants (VILAR), Moscow, Russia. Е-mail: polakov@yandex.ru
V.A. Dubinskaya - Ph.D., Leading Research, All-Russian Scientific Institute of Medicinal and Aromatic Plants (VILAR), Moscow, Russia. E-mail: va@diamsoft.ru
D.S. Kachalin - Post-graduate Student of Department of Pharmaceutical Technologies of All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (VILAR), Russia
V.F. Okhotnikova - Ph.D.(Pharm.), Manager of Pharmaceutical Technology Section, All-Russian Scientific Institute of Medicinal and Aromatic Plants (VILAR), Moscow, Russia. E-mail: vilarnii@mail.ru
T.V. Kachalina - Ph.D.(Pharm.), Leading Research Worker, All-Russian Institute of Medicinal and Aromatic Plants, Moscow, Russia. E-mail: t.kachalina@rambler.ru
T.А. Sokolskaya - Dr.Sc.(Pharm.), Professor, Russian Science Research Institution for Medicinal and Aromatic Plants (VILAR). E-mail: vilarnii@mail.ru
Abstract:
The development of effective, safe pharmaceutical drugs with appropriate level of quality is important. The solution to this problem is to use science-based approach of studying properties and technological characteristics of dosage forms and their components by modern methods. Already at early stage of development of dosage forms possible interactions of components should be identified to predict incompatibility of individual components, to identify compositions of tablet and temperature conditions during manufacture and storage. Developed scientific based assessment of physico-chemical properties of components of solid dosage forms by modern methods allows to predict the compatibility of excipients and active ingredient, to study the nature of their interaction, to conduct selection of excipients, as well as to determine the presence of drug substance lutenurinum in the solid dosage form.
Pages: 103-107
References

  1. Verstakova O.L. Oczenka vliyaniya vspomogatel'ny'x veshhestv na bezopasnost' farmakologicheskix sredstv // Farmateka. 1998. № 4. S. 21-22.
  2. Aleeva G.N., Zhuravleva M.V., Xafiz'yanova R.X. Rol' vspomogatel'ny'x veshhestv v obespechenii farmaczevticheskix i terapevticheskix svojstv lekarstvenny'x preparatov (obzor) // Ximiko-farmaczevticheskij zhurnal. 2009. T. 43. № 4. S. 51-55.
  3. E'pshtejn N.A. Test farmaczevticheskoj sovmestimosti lekarstvenny'x i vspomogatel'ny'x veshhestv v razrabaty'vaemy'x formax zadannogo sostava // Ximiko-farmaczevticheskij zhurnal. 1995. T. 9. № 3. S. 51-53.
  4. Bojko B.N. Prikladnaya mikrokalorimetriya. M.: Nauka. 2006. 69 s.
  5. Slabicky R.O. Water for Pharmaceutical use / Slabicky R. O // In: Encyclopedia of Pharmaceutical Technology. Vol. 16: Unit processes in pharmacy: the operations to zeta potential. 1997 P. 293-306.
  6. The United States Pharmacopoeia. 30th Revision. 2007.
  7. British Pharmacopoeia. 2007. Version 11,0.
  8. Ue'ndlandt U. Termicheskie metody' analiza: per. s ang. V.A. Stepanova i V.A. Bershtejna. M.: Mir. 1978. 526 s.