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Influence of Prosolv and Prosolv:Mannitol 200 direct compression fillers on the physicomechanical properties of atorvastatin oral dispersible tablets.
Pharm Dev Technol. 2015 Jun; 20(4):394-400.PD

Abstract

The objective of the present study was to evaluate the influence of Prosolv® and Prosolv®: Mannitol 200 direct compression (DC) fillers on the physicomechanical characteristics of oral dispersible tablets (ODTs) of crystalline atorvastatin calcium. ODTs were formulated by DC and were analyzed for weight uniformity, hardness, friability, drug content, disintegration and dissolution. Three disintegration time (DT) test methods; European Pharmacopoeia (EP) method for conventional tablets (Method 1), a modification of this method (Method 2) and the EP method for oral lyophilisates (Method 3) were compared as part of this study. All ODTs showed low weight variation of <2.5%. Prosolv® only ODTs showed the highest tablet hardness of ∼ 73 N, hardness decreased with increasing mannitol content. Friability of all formulations was <1% although friability of Prosolv®:Mannitol ODTs was higher than for pure Prosolv®. DT of all ODTs was <30 s. Method 2 showed the fastest DT. Method 3 was non-discriminatory giving a DT of 13-15 s for all formulations. Atorvastatin dissolution from all ODTs was >60% within 5 min despite the drug being crystalline. Prosolv® and Prosolv®:Mannitol-based ODTs are suitable for ODT formulations by DC to give ODTs with high mechanical strength, rapid disintegration and dissolution.

Authors+Show Affiliations

School of Pharmacy, Royal College of Surgeons in Ireland , Dublin , Ireland.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24397821

Citation

Gowda, Veeran, et al. "Influence of Prosolv and Prosolv:Mannitol 200 Direct Compression Fillers On the Physicomechanical Properties of Atorvastatin Oral Dispersible Tablets." Pharmaceutical Development and Technology, vol. 20, no. 4, 2015, pp. 394-400.
Gowda V, Pabari RM, Kelly JG, et al. Influence of Prosolv and Prosolv:Mannitol 200 direct compression fillers on the physicomechanical properties of atorvastatin oral dispersible tablets. Pharm Dev Technol. 2015;20(4):394-400.
Gowda, V., Pabari, R. M., Kelly, J. G., & Ramtoola, Z. (2015). Influence of Prosolv and Prosolv:Mannitol 200 direct compression fillers on the physicomechanical properties of atorvastatin oral dispersible tablets. Pharmaceutical Development and Technology, 20(4), 394-400. https://doi.org/10.3109/10837450.2013.871031
Gowda V, et al. Influence of Prosolv and Prosolv:Mannitol 200 Direct Compression Fillers On the Physicomechanical Properties of Atorvastatin Oral Dispersible Tablets. Pharm Dev Technol. 2015;20(4):394-400. PubMed PMID: 24397821.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influence of Prosolv and Prosolv:Mannitol 200 direct compression fillers on the physicomechanical properties of atorvastatin oral dispersible tablets. AU - Gowda,Veeran, AU - Pabari,Ritesh M, AU - Kelly,John G, AU - Ramtoola,Zebunnissa, Y1 - 2014/01/08/ PY - 2014/1/9/entrez PY - 2014/1/9/pubmed PY - 2016/2/5/medline KW - Atorvastatin calcium KW - Prosolv KW - disintegration method KW - disintegration time KW - mannitol KW - orodispersible tablets SP - 394 EP - 400 JF - Pharmaceutical development and technology JO - Pharm Dev Technol VL - 20 IS - 4 N2 - The objective of the present study was to evaluate the influence of Prosolv® and Prosolv®: Mannitol 200 direct compression (DC) fillers on the physicomechanical characteristics of oral dispersible tablets (ODTs) of crystalline atorvastatin calcium. ODTs were formulated by DC and were analyzed for weight uniformity, hardness, friability, drug content, disintegration and dissolution. Three disintegration time (DT) test methods; European Pharmacopoeia (EP) method for conventional tablets (Method 1), a modification of this method (Method 2) and the EP method for oral lyophilisates (Method 3) were compared as part of this study. All ODTs showed low weight variation of <2.5%. Prosolv® only ODTs showed the highest tablet hardness of ∼ 73 N, hardness decreased with increasing mannitol content. Friability of all formulations was <1% although friability of Prosolv®:Mannitol ODTs was higher than for pure Prosolv®. DT of all ODTs was <30 s. Method 2 showed the fastest DT. Method 3 was non-discriminatory giving a DT of 13-15 s for all formulations. Atorvastatin dissolution from all ODTs was >60% within 5 min despite the drug being crystalline. Prosolv® and Prosolv®:Mannitol-based ODTs are suitable for ODT formulations by DC to give ODTs with high mechanical strength, rapid disintegration and dissolution. SN - 1097-9867 UR - https://www.unboundmedicine.com/medline/citation/24397821/Influence_of_Prosolv_and_Prosolv:Mannitol_200_direct_compression_fillers_on_the_physicomechanical_properties_of_atorvastatin_oral_dispersible_tablets_ L2 - http://www.tandfonline.com/doi/full/10.3109/10837450.2013.871031 DB - PRIME DP - Unbound Medicine ER -