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Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization.
Aldawsari, Hibah M; Naveen, N Raghavendra; Alhakamy, Nabil A; Goudanavar, Prakash S; Rao, Gsn Koteswara; Budha, Roja Rani; Nair, Anroop B; Badr-Eldin, Shaimaa M.
Afiliación
  • Aldawsari HM; Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Naveen NR; Center of Excellence for Drug Research and Pharmaceutical Industries, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Alhakamy NA; Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Karnataka, India.
  • Goudanavar PS; Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Rao GK; Center of Excellence for Drug Research and Pharmaceutical Industries, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Budha RR; Mohamed Saeed Tamer Chair for Pharmaceutical Industries, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Nair AB; Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Karnataka, India.
  • Badr-Eldin SM; Department of Pharmacy, School of Medical and Allied Sciences, Galgotias University, Greater Noida, India.
Drug Deliv ; 29(1): 2258-2268, 2022 Dec.
Article en En | MEDLINE | ID: mdl-35838522
Pulsatile drug delivery systems have drawn attention in contemporary research for designing chronotherapeutic systems. The current work aims to design pulsatile ketorolac tromethamine tablets using compression coating for delayed delivery with a lag time suitable for the treatment of morning stiffness in arthritis. Rapidly disintegrating core tablets of ketorolac tromethamine were formulated using super-disintegrants, and the optimized formulation was compression using PEO WSR coagulant and Eudragit RLPO for delaying the release. The central composite design and response surface methodology were employed to optimize the formulation and process parameters namely PEO WSR Coagulant (X1), Eudragit RLPO (X2), and Hardness (X3). The dependent variables optimized were lag time and time required for 95% drug release. Analysis using response surface graphs and mathematical modeling of the results allowed identifying and quantifying the formulation variables active on the selected responses. A polynomial equation fitted to the data was used to predict the composition with optimum responses. Compression-coated pulsatile tablets' optimized composition exhibited a lag time of 9 h and released 95% of the ketorolac tromethamine in 17.42 h. Validation of the mathematical model assured the reliability of QBD in formulation design. In vivo X-ray imaging and pharmacokinetic studies established a strong relationship between the coated polymers maintaining the desired lag time for delayed delivery of the active to coincide with the chronobiology for enhanced bioavailability at the right time when needed.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Química Farmacéutica / Ketorolaco Trometamina Tipo de estudio: Prognostic_studies Idioma: En Revista: Drug Deliv Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article País de afiliación: Arabia Saudita Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Química Farmacéutica / Ketorolaco Trometamina Tipo de estudio: Prognostic_studies Idioma: En Revista: Drug Deliv Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2022 Tipo del documento: Article País de afiliación: Arabia Saudita Pais de publicación: Reino Unido