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Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation.

ABSTRACT: OBJECTIVE:To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market. RESULTS:A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25-75% of manufacture-expiration period. Weight variation (range as% difference from mean, n?=?20), active substance content (ASC, mean (SD) as% difference from label, n?=?20), hardness (mean (SD), n?=?10), and friability (% weight loss, n?=?20) were 97-103%, 102.0% (3.4%), 15.4 (1.1) kg, and 0.24%, respectively, for the reference. For G2-7, they were???±5%, 98.6% (4.0%) to 109.9% (1.8%), 11.9 (0.9) to 18.3 (0.8) kg, and???0.00 to 0.75%, respectively. G1 ASC, hardness, and friability were 111.3% (1.7%), 20.1 (1.7) kg, and 1.10%, respectively. Disintegration time (n?=?6) and dissolution profile (n?=?8) were also determined. No formulation disintegrated or released ??0.1% of label ASC in 0.1 N HCl for 2 h. The reference disintegrated in 15:00 min:seconds and released a mean (range) of 100% (99-103%) of label ASC by 45 min in phosphate buffer (pH?=?6.8). G1-7 disintegrated in 8:53 to 20:37 min:seconds and released 81% (69-90%) (G1) to 109%. Except for borderline performance of G1, all formulations passed in vitro quality tests according to United States Pharmacopoeia.

SUBMITTER: Hammami MM

PROVIDER: S-EPMC7491129 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation.

Hammami Muhammad M MM Hussein Rajaa F RF AlSwayeh Reem R Alvi Syed N SN

BMC research notes 20200914 1

<h4>Objective</h4>To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market.<h4>Results</h4>A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25-75% of manufacture-expiration period. Weight variation (range as% difference from mean, n = 20), active substance content (ASC, mean (SD) as% difference from label, n = 20), hardness (mean (SD), n = 10), and friability (% w ...[more]

PMID: 32928294

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Project description:Background and objectiveVenetoclax is an approved BCL-2 inhibitor, currently under evaluation in different hematological malignancies in adult and pediatric populations. Venetoclax is available as 10, 50, and 100 mg tablets. To provide an alternative to patients who find taking the commonly prescribed 100 mg tablet a challenge, the interchangeability of lower-strength tablets with the 100 mg tablet was investigated. Additionally, newly developed oral suspension powder formulations to facilitate dosing in pediatrics were evaluated.MethodsPharmacokinetic data from 80 healthy female participants from three phase I studies were utilized to evaluate the bioavailability of (1) 10 and 50 mg tablets relative to a 100 mg tablet; (2) 0.72 and 7.2% (drug to total weight) oral powder formulations relative to the 100 mg tablet; and (3) oral powder formulations administered using different vehicles (apple juice, apple sauce, and yogurt) relative to water under fed conditions.ResultsBioavailability assessments at a 100 mg dose of venetoclax demonstrated bioequivalence across the 10, 50, and 100 mg tablet strengths. Oral powder formulations met the bioequivalence criteria (0.80-1.25) with respect to area under the concentration-time curve to time of the last measurable concentration (AUCt) and to infinite time (AUC∞) but exhibited a slightly lower maximum plasma concentration (Cmax). Exposure-response analyses were utilized to demonstrate that the lower Cmax observed with the powder formulations is not clinically meaningful. The delivery vehicles tested did not affect the bioavailability of venetoclax oral powder formulations.ConclusionsThe smaller-sized tablets (10 and 50 mg) and the newly developed oral powder formulations of venetoclax can be used interchangeably with the 100 mg tablets to improve the patients' experience, while maintaining adequate exposure. CLINICAL TRIALS IDENTIFIERS: NCT01682616, 11 September 2012; NCT02005471, 9 December 2013; NCT02242942, 17 September 2014; NCT02203773, 30 July 2014; NCT02287233, 10 November 2014; NCT02993523, 15 December 2016; NCT03069352, 3 March 2017.

Dataset Information

Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation.

Publications

Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation.

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