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Physicochemical attributes and dissolution testing of ophthalmic ointments.
Bao, Quanying; Jog, Rajan; Shen, Jie; Newman, Bryan; Wang, Yan; Choi, Stephanie; Burgess, Diane J.
Afiliación
  • Bao Q; University of Connecticut, School of Pharmacy, Storrs, CT 06269, USA.
  • Jog R; University of Connecticut, School of Pharmacy, Storrs, CT 06269, USA.
  • Shen J; University of Connecticut, School of Pharmacy, Storrs, CT 06269, USA.
  • Newman B; FDA/CDER, Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance, Silver Spring, MD 20993, USA.
  • Wang Y; FDA/CDER, Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance, Silver Spring, MD 20993, USA.
  • Choi S; FDA/CDER, Office of Generic Drugs, Office of Research and Standards, Division of Therapeutic Performance, Silver Spring, MD 20993, USA.
  • Burgess DJ; University of Connecticut, School of Pharmacy, Storrs, CT 06269, USA. Electronic address: d.burgess@uconn.edu.
Int J Pharm ; 523(1): 310-319, 2017 May 15.
Article en En | MEDLINE | ID: mdl-28344172
The investigation of semisolid ophthalmic ointments is challenging due to their complex physicochemical properties and the unique anatomy of the human eye. Using Lotemax® as a model ophthalmic ointment, three different manufacturing processes and two excipient sources (Fisher® (OWP) and Fougera® (NWP)) were used to prepare loteprednol etabonate ointments that were qualitatively and quantitatively the same across the manufactured formulations. Physicochemical properties including drug content and uniformity, particle size and distribution, as well as rheological parameters (onset point, crossover modulus, storage modulus and Power law consistency index) were investigated. In addition, USP apparatus 2 with enhancer cells was utilized to study the in vitro drug release characteristics of the ophthalmic ointments. Both manufacturing processes and excipient sources had a significant influence on the physicochemical attributes and the in vitro drug release profiles of the prepared ointments. Ointments prepared via the hot melt processes exhibited higher rheological parameters and lower drug release rates compared to ointments prepared without hot melting. Ointments prepared with OWP demonstrated higher rheological parameters and lower in vitro drug release rates compared to ointments prepared with NWP. A strong correlation between the rheological parameters and in vitro drug release rate was shown using logarithmic linear regression. This correlation may be useful in predicting in vitro drug release from measured physicochemical properties, and identifying the critical quality attributes during the development of ointment formulations.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pomadas Tipo de estudio: Prognostic_studies Idioma: En Revista: Int J Pharm Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos
Texto completo
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PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pomadas Tipo de estudio: Prognostic_studies Idioma: En Revista: Int J Pharm Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos