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Horizonte Médico (Lima)

Print version ISSN 1727-558X


ALVARADO YARASCA, Ángel et al. Determination of therapeutic range and study of biopharmaceutical equivalence of two multisource Digoxin tablets of 0.25 mg. Horiz. Med. [online]. 2014, vol.14, n.4, pp.48-52. ISSN 1727-558X.

Objective: To determine the therapeutic safety theoretically and experimentally, the biopharmaceutical equivalence parameters of two batches of multisource Digoxin tablets of 0.25mg. Material and Methods: Two batches, each of 200 tablets multisource digoxin 0.25 mg were studied, assigning code multisource TDH025 Lot 105031 and TDF025 Lot 10940431. The therapeutic range was determined by theoretical formula VT = αFraction pharmacokinetics / αpredicted fraction by usual concentration x, then by the difference CmE and CME, the therapeutic range was obtained. The analytical method used for quantification of the active ingredient, was described in The International Pharmacopoeia of the World Health Organization (WHO); while the fretting test and the hardness was determined according to the USP. Results: The therapeutic index is 1.2 ng/ml; and evaluation of the parameters of the biopharmaceutical equivalence percentages of active ingredient of the two lots of multisource drugs are within the acceptance range (90-110%) given in the USP and WHO. The fretting of TDH025 fretting batch 105031 was 0.55% and TDF025 was 0.56%, both values are below 1% which is acceptable value; and hardness indicates an acceptable mechanical shock endurance. The 06 tablets were completely disintegrated, passing through a No. 10 (1700 uM) sieve, in a dissolution medium simulating gastric and intestinal pH in less than 5 min. Conclusion: Biopharmaceutical equivalence of multisource drugs digoxin 0.25 mg TDH025 TDF025 batch batch 105031 and 10940431 was demonstrated according to the acceptance criteria of the WHO and USP, the active ingredient (digoxin) quantified in each batch were within the range of 90-110%; attrition and hardness parameters indicate adequate stability in their lifetime.

Keywords : Therapeutic range; biopharmaceutical equivalence multisource drug digoxin.

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