IN VITRO CEFIXIME DISSOLUTION IN PHARMACOPEIA-RECOMMENDED MEDIUM AND SIMULATED GASTROINTESTINAL FLUIDS: A COMPARATIVE STUDY
DOI:
https://doi.org/10.22159/ajpcr.2019.v12i12.35966Keywords:
Cefixime, Simulated gastrointestinal fluids, Dissolution, Fed, Fasted, PharmacopeiaAbstract
Objectives: The aim of this study was to compare in vitro dissolution of cefixime in a pharmacopeial-recommended medium and in simulated gastrointestinal fluids.
Methods: Before dissolution testing, the drug content in the tested materials was determined by ultraviolet spectrophotometer. The dissolution media used in this study were recommended by the United States Pharmacopeia (USP) as well as four different media that mimic gastric and intestinal fluids in fed and fasted states. The tested materials included the pure drug and two 0.2-g capsule brands (original and test).
Results: The pharmacopeial medium showed no difference in both extent and rate of the drug dissolution between the tested materials. In the contrary, the difference was significant when the simulated fluids were used. Moreover, it was found that the simulated intestinal fluid (SIF) of fed state showed 21–32% decrement in the drug dissolution compared to that of the corresponding fasted-state simulated fluid. Indeed, this finding agreed those of in vivo bioavailability studies published in literature.
Conclusion: The SIF is much more valid as a medium for in vitro testing of cefixime capsule than the one recommended by the USP.
Downloads
References
United States Pharmacopeia Commission. United States Pharmacopeia and National formulary. USP 29-NF24. Washington, D.C:United States Pharmacopeia Commission; 2006.
Suparx®, Cefixime Oral. Available from: https://www.accessdata.fda. gov/drugsatfda_docs/label/2004/50621slr023,50622slr017_suprax_lbl. pdf. [Last accessed on 2019 Apr].
Malia D. Zero, first, second order derivative and area under curve spectrophotometric methods for determination of cefixime trihydrate in pharmaceutical formulation. Int J Pharm Pharm Sci 2015;7:321-5.
Kumar V, Kalaiselvan V, Kumar AP, Saurabh A, Thota P, Sidhu S, et al. Cefixime-associated acute generalized exanthematous pustulosis: Rare cases in India. Indian J Pharmacol 2018;50:204-7.
Duverne C, Bouten A, Deslandes A, Westphal JF, Trouvin JH, Farinotti R, et al. Modification of cefixime bioavailability by nifedipine in humans: Involvement of the dipeptide carrier system. Antimicrob Agents Chemother 1992;36:2462-7.
Mahd ZH, Maraie NK, AL-Juboori ZA. Application of liquisolid technology to enhance the dissolution of cefixime from its oral capsules. Int J Appl Pharm 2018;10:214-9.
Danafar H, Hamidic M. Pharmacokinetics and bioequivalence study of two formulations of cefixime in healthy male volunteers. Iran J Pharm Sci 2016;12:1-14.
Custodio JM, Wu CY, Benet LZ. Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption. Adv Drug Deliv Rev 2008;60:717-33.
Mogal P, Derle D. Cefixime, in general, class 4 drug but individually class 2 drugs. J Med Physiol Ther 2017;1:1-10.
Cefixime, Medscape Website; WebMD LLC. Available from: https:// www.reference.medscape.com/drug/suprax-cefixime-342503. [Last accessed on 2019 Apr].
Taylor K, Aulton M. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. United Kingdom: Churchill Livingstone; 2018. p. 254-8.
Klein S. The use of biorelevant dissolution media to forecast the in vivo performance of a drug. AAPS J 2010;12:397-406.
Pan XM, Li J, Gan R, Hu XN. Preparation and in vitro evaluation of enteric-coated tablets of rosiglitazone sodium. Saudi Pharm J 2015;23:581-6.
Shah R, Patel S, Patel H, Pandey S, Shah S, Shah D. Development and validation of dissolution method for carvedilol compression-coated capsules. Braz J Pharm Sci 2011;47:899-906.
Dangi AA, Ashok G, Divya J. Formulation and evaluation of colon targeted drug delivery system of levetiracetam using pectin as polymeric carrier. J Appl Pharm Sci 2013;3:78-87.
Diaz DA, Colgan ST, Langer CS, Bandi NT, Likar MD, Van Alstine L, et al. Dissolution similarity requirements: How similar or dissimilar are the global regulatory expectations? AAPS J 2016;18:15-22.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
