Spherical Crystallization of Rosuvastatin Calcium for Enhanced Solubility, Dissolution, and Direct Compression Properties
1, 1, 1
- 1Department of Pharmaceutics, MVP Samaj’s College of Pharmacy, Nashik, Savitribai Phule Pune University, Pune, Maharashtra, INDIA.
CORRESPONDENCE
Supriya B. Sandhan
Department of Pharmaceutics, MVP Samaj’s College of Pharmacy, Nashik, Savitribai Phule Pune University, Pune, Maharashtra, INDIA.
Volume 60, Issue 5 (KrupaPharmaCon 2026) · pp. 54-65 · 2026 · DOI: 10.5530/ijper.krupapharmacon.23
ABSTRACT
Objectives: Rosuvastatin calcium is crystalline, BCS Class II drug having low solubility and bioavailability approximately 20%. Crystalline nature of drug result in poor dissolution, flowability, and compressibility, which limit its direct compression. The aim of study is to develop and evaluate spherical agglomerates of rosuvastatin to enhance solubility, dissolution, and manufacturability.Materials and Methods: Spherical agglomerates of Rosuvastatin were prepared by using the solvent change approach. Acetone, a good solvent; dichloromethane, the bridging liquid; and water, poor solvent, were used along with HPMC E5 as a stabilizer to synthesize the ternary system. The central composite design was employed to optimize the formulation where HPMC content and stirrer speed were selected as independent variables and % drug released and Carr's index as responses (dependent variables). Spherical agglomerates of rosuvastatin were further characterized using microscopy, FTIR, DSC, and XRPD studies and evaluated for flow and compressibility properties along with compression studies.Results: The spherical agglomerates of rosuvastatin possessed a uniform spherical morphology and lower crystallinity. Hydrogen bonding was detected by FTIR and DSC studies of the drug and HPMC E5 without any incompatibilities. XRPD analysis proved crystallinity of rosuvastatin is reduced by 44.44%. Compared to rosuvastatin, agglomerated forms presented better physical properties such as higher flowability, increased bulk density, and good compressibility, being thus appropriate for direct compression. The dissolution of the tablets based on agglomerates was found to be significantly improved compared to conventional rosuvastatin tablets.Conclusion: The present study has shown successful improvement in dissolution characteristics and tableting ability because of alteration in particle size and amorphization of spherical rosuvastatin agglomerates. Spherical crystallization with HPMC E5 may therefore be considered an interesting approach to increase the solubility, processability, and potential bioavailability of rosuvastatin calcium.
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Wagh, M. P., Sandhan, S. B., & Patil, P. M. (2026). Spherical Crystallization of Rosuvastatin Calcium for Enhanced Solubility, Dissolution, and Direct Compression Properties. Indian Journal of Pharmaceutical Education and Research, 60(5), 54-65. https://doi.org/10.5530/ijper.krupapharmacon.23
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