Diclofenac sodium multisource prolonged release tablets—a comparative study on the dissolution profiles

Bertocchi, Paola; Antoniella, Eleonora; Valvo, Luisa; Alimonti, S.; Memoli, Adriana

doi:10.1016/j.jpba.2004.11.041

Cited by 37 publications

(31 citation statements)

References 12 publications

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“…27,67 SIF without pancreatin and SIF without pancreatin with 1% (w/v) Tween 20 has been suggested as discriminatory dissolution media for diclofenac sodium prolonged release tablets. 68 Dissolution in these media can be considered as discriminatory dissolution test for IR dosage forms. The BCS Guidance prescribes comparative in vitro dissolution testing between test and comparator in pH 1.2, 4.5, and 6.8 buffers and also provides criteria for the assessment of dissolution profile similarity.…”

Section: Surrogate Techniques For In Vivo Be Testingmentioning

confidence: 99%

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Chuasuwan

Binjesoh

Polli

et al. 2009

Journal of Pharmaceutical Sciences

143

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Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8.

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Section: Surrogate Techniques For In Vivo Be Testingmentioning

confidence: 99%

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Chuasuwan

Binjesoh

Polli

et al. 2009

Journal of Pharmaceutical Sciences

143

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“…This less effective hydrodynamic is sometimes reported. 29,30 A general increase in the dissolution rate and extent was observed for all formulations using the basket apparatus under strong agitation conditions (100 rpm) compared to the values obtained using the paddle at 50 rpm (Figures 4, 5, 6 and 7). This result was confirmed by the increased dissolution efficiency values (Table 3).…”

Section: Resultsmentioning

confidence: 73%

Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets

Cruz¹,

Bertol²,

Murakami³

et al. 2013

Quím. Nova

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Recebido em 16/5/12; aceito em 12/10/12; publicado na web em 21/2/13A simple, precise, specific, repeatable and discriminating dissolution test for primaquine (PQ) matrix tablets was developed and validated according to ICH and FDA guidelines. Two UV assaying methods were validated for determination of PQ released in 0.1 M hydrochloric acid and water media. Both methods were linear (R 2 >0.999), precise (R.S.D.<1.87%) and accurate (97.65-99.97%). Dissolution efficiency (69-88%) and equivalence of formulations (f2) was assessed in different media and apparatuses (basket/100 rpm and paddle/50 rpm) tested. Discriminating condition was 900 mL aqueous medium, basket at 100 rpm and sampling times at 1, 4 and 8 h. Repeatability (R.S.D.<2.71%) and intermediate precision (R.S.D.<2.06%) of dissolution method were satisfactory.

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“…The selection of excipients yields capsules of the desired active substance release profile and subsequent bioavailability of the drug [3]. Microcrystalline cellulose is a polysaccharide composed of D-glucose units linked together by a β-1,4-bond.…”

Section: Original Papersmentioning

confidence: 99%

Influence of Polymer Type on the Physical Properties and Release Profile of Papaverine Hydrochloride From Hard Gelatin Capsules

et al. 2015

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Diclofenac sodium multisource prolonged release tablets—a comparative study on the dissolution profiles

Cited by 37 publications

References 12 publications

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium

Development and validation of a dissolution test for primaquine/polyethylene oxide matrix tablets

Influence of Polymer Type on the Physical Properties and Release Profile of Papaverine Hydrochloride From Hard Gelatin Capsules

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