Application of biopharmaceutical system of classification in development of new medicinal preparations

Authors

  • S. N. Gureyeva JSC «Farmak»,
  • O. S. Albedhani SHEI «I.Ya. Horbachevsky Ternopil State Medical University MOH of Ukraine»,
  • T. A. Groschoviy SHEI «I.Ya. Horbachevsky Ternopil State Medical University MOH of Ukraine»,

DOI:

https://doi.org/10.14739/2409-2932.2015.3.52383

Keywords:

Biopharmaceutical Classification System, Bioequivalence, Bioavailability, Solubility, Drag Dissolution, Permeability

Abstract

Aim. In order to determine the role of the biopharmaceutical classification system in the development of new drugs, the concept of bioavailability and bioequivalence has been investigated.

Methods and results. Theoretically analysis of application of BCS in pharmaceutical development of solid dosage forms and systems analysis of research, relating to BCS has been studied.

Article shows the analysis of the scientific researches of BSС and original sources application in the scientific bases of world level of SciTech development, a comparative analysis of freeing and absorption operating substances’ models, introduction of generic pharmaceutical preparations based on EMA, FDA, USP, WHO regulator documents.

Conclusion. Biopharmaceutical classification system is a powerful factor in the development of new and effective generic drugs.

References

Ramenskaya, H. V., Shokhin I. E., & Savchenko A. Yu. (2012) Biofarmacevticheskaya model' ocenki vzaimozamenyaemosti vosproizvedennykh LS po ikh rastvorimosti, metabolizmu i ′eliminacii (BDDCS) [Biopharmaceutical evaluation model of interchangeability of generic drugs on their solubility, metabolism and elimination (BDDCS)]. Biomediciyna, 2, 50–57. [in Russian].

Redkin, R. H., Shmyrova, Yu. V., & Andriichuk, Ya. R. (2010) Vyvchennia fizyko-khimichnykh i tekhnolohichnykh vlastyvostei novoi substantsii z antykoahuliantnoiu aktyvnistiu [Study of the physico-chemical and technological properties of a new substance with anticoagulant activity]. Ukrainskyi biofarmatsevtychnyi zhurnal, 6(11), 16. [in Ukrainian].

Holovenko, M. Ya., Baula, O. P., & Borysiuk, I. Yu. (2010) Biofarmatsevtychna klasyfikatsiina systema [Biopharmaceutical classification system]. Kyiv [in Ukrainian].

Hureieva, S. M. (2014) Doslidzhennia bioekvivalentnosti tverdykh likarskykh form na prykladi tabletok bisoprololu fumaratu vidpovidno do biofarmatsevtychnoi klasyfikatsiinoi systemy [Bioavailability research of solid medicinal forms by the example of bisoprolol fumarate tablets in relation to the biopharmaceutical classification system]. Visnyk farmatsii, 2, 10–14. [in Ukrainian].

Hureieva, S. M. (2012) Mistse ta rol biofarmatsevtychnoi klasyfikatsiinoi systemy i vykorystannia yii yak instrumentu pry stvorenni bioekvivalentnykh tverdykh likarskykh form [Place and role of biopharmaceutical classification system and use it as a tool for creating solid dosage forms are bioequivalent]. Ukrainskyi zhurnal laboratornoi ta klinichnoi medytsyny, 3, 6–10. [in Ukrainian].

Maltsev, V. I., Liapunov, M. O., Chumak, V. T., et al. (2005) Nastanovy z klinichnykh doslidzhen. Likarski zasoby. Doslidzhennia biodostupnosti ta bioekvivalentnosti. Nastanova 42–7.1:2005 [Guidelines for clinical research. Medicines. Investigation of Bioavailability and Bioequivalence. Guidelines 42-7.1: 2005]. Kyiv: Ministerstvo okhorony zdorovia Ukrainy [in Ukrainian].

(2013) Nakaz Ministerstva okhorony zdorovia Ukrainy Poriadok provedennia ekspertyzy reiestratsiinykh materialiv na likarski zasoby, shcho podaiutsia na derzhavnu reiestratsiiu (perereiestratsiiu), a takozh ekspertyzy materialiv pro vnesennia zmin do reiestratsiinykh materialiv protiahom dii reiestratsiinoho posvidchennia. Rozd. 2. Vid 4 lyp. 2013 roku №3 [Order of the Ministry of Health of Ukraine The order of examination of registration materials of medicinal products submitted for state registration (re-registration), and evaluated the changes to registration materials during the validity period of registration certificate. Part. 2. from 1 April 2013, №3]. Retrieved from http://zakon4.rada.gov.ua/laws/show/z0425-13. [in Ukrainian].

Chumak, V. T., Baula, O. P., & Soloviov, A. I. (2007) Provedennia porivnialnykh doslidzhen in vitro dlia pidtverdzhennia ekvivalentnosti likarskykh zasobiv u tverdii dozovanii formi systemnoi dii: metodychni rekomendatsii [Comparative research in vitro to confirm the equivalence of drugs in solid dosage form for systemic effects: guidelines]. Kyiv: Morion [in Ukrainian].

Shohin, I. E., Ramenskaya, G. V., Yarushok, T. A., Zimakova, E. A., Vasilenko, G. V. & Davudova, K. S. (2011) Procedura «biovejver» dlya vitaminnykh preparatov na primere vosproizvedennykh lekarstvennykh sredstv folievoj kisloty [Procedure «biowaiver» for the example of vitamin preparations generics drugs folic acid]. Vestnik Roszdravnadzora, 1, 64. [in Russian].

Hureieva, S. M., Zaidze, A. V., Stelmakh, A. M., & Yakovenko, O. M. (2011) Rozrobka ta validatsiia metodyky doslidzhennia profiliv rozchynennia tabletok valatsykloviru hidrokhlorydu [Development and validation of the dissolution of the preparation hydrochloride in the form of the tablets]. Farmatsevtychnyi chasopys, 4(20), 68–72. [in Ukrainian].

Bergstrom, C. A., Strafford, M., Lazorova, L., Avdeef, A., Luthman, K., & Artursson, P. (2003) Absorption classification of oral drugs based on molecular surface properties. J. Med. Chem., 46, 558–570. doi: 10.1021/jm020986i.

Kapoor, Ankita, Sharma, Richa, & Sharma, Pankaj (2014) BCS Classification System: Benchmark for solubility and permeability. American Journal of Pharmaceutical Research, 4, 2233–2238.

Yasir, H., Asif, H., & Kumar, A. (2010) Biopharmaceutical classification system: An account. Int. J. PharmTech Res., 2(3), 1681–1690.

Rohilla, S., Rohilla, A., Marwah, R. K., & Nanda, A. (2011) Biopharmaceutical classification system: A strategic tool for classifying drug substances. Int. Res. J. Pharm., 2(70), 53–59.

Budhwaar, Vikaas, & Nanda, Arun (2012) The Biopharmaceutical classification system (BCS): present and future prospective. Int. Res. J. Pharm., 3(9), 7–11.

Chavda, H. V., Patel, C. N., & Anand, I. S. (2010) Biopharmaceutical classification system. Syst. Rev. Pharm., 1, 62–69.

Cook, J., Addicks, W., & Wu, Y. H. (2008) Application of the Biopharmaceutical Classification System in Clinical Drug Development – An Industrial View. AAPS J., 10(2), 306–310. doi: 10.1208/s12248-008-9036-5.

Cook, J. A., Davit, B. M., & Polli, J. E. (2010) Impact of Biopharmaceutical Classification System-Based Biowaiver. Mol. Pharm., 7(5), 1539–1544. 10.1021/mp1001747.

(2010). CPMP/EWP/QWP/1401/98/ Rev.1. Guideline on the Investigation of Bioeguivalence.

Dash, V., & Kesari, A. (2011) Role of Biopharmaceutical Classification system in drug development Program. J. Curr. Pharm. Res., 5(1), 28–31.

(2000). FDA – Guidance for Industry. Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based an a Biopharmaceutical Classification System.

Gohel, M. C. (2005) An audit of recent inputs on biopharmaceutical classification system. Pharm. Rev., 3(1).

Khar, R. K., & Pandita, D. (2005) Biopharmaceutical classification system and its importance. The Indian Pharmacist, 4(41), 25–30.

Lindenberg, M., Kopp, S., & Dressman, J. B. (2004) Classification of orally administered drugs on the World Health Organization model list of essential medicines according to the biopharmaceutics classification system. Eur. J. Pharm. Biopharm., 58, 265–278. doi:10.1016/j.ejpb.2004.03.001.

Lipinski, C. A. (2000) Drug-like properties and the causes of poor solubility and poor permeability. J. Pharmacol Toxicol Methods., 44(1), 235–249. doi:10.1016/S1056-8719(00)00107-6.

Polli, J. E., Yu, L. X., Cook, J. A., Amidon, G. L., Borchardt, R. T., Burnside, B. A., et al. (2004) Biopharmaceutics classification system - implementation challenges and extension opportunities. J. Pharm. Sci., 93(6), 1375–1381. doi: 10.1002/jps.20064.

Reddy, B. B. K., & Karunakar, A. (2011) Biopharmaceutics classification system: a regulatory approach. Dissolution Technologies, 18(1), 31–37.

Sachan, N. K., Bhattacharya, A., Pushkar, S., & Mishra, A. (2009) Biopharmaceutical classification system: A strategic tool for oral drug delivery technology. Asian Journal of Pharmaceutic, 3, 76–81.

Shugarts, S., & Benet, L. Z. (2009) The Role of Transporters in the Pharmacokinetics of Orally Administered Drugs. Pharm. Res., 26(9), 2039–2054. doi: 10.1007/s11095-009-9924-0.

Chen, M. L., Amidon, G. L., Benet, L. Z., et al. (2011) The BCS, BDDCS and Regulatory Guidances. Pharm. Res., 28, 1774–1778.

Downloads

How to Cite

1.
Gureyeva SN, Albedhani OS, Groschoviy TA. Application of biopharmaceutical system of classification in development of new medicinal preparations. Current issues in pharmacy and medicine: science and practice [Internet]. 2015Nov.3 [cited 2024Nov.23];(3). Available from: http://pharmed.zsmu.edu.ua/article/view/52383

Issue

No. 3 (2015)

Section

Pharmaceutical manufacturing

License

Authors who publish with this journal agree to the following terms:

    1. Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.     Лицензия Creative Commons
    2. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
    3. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access)