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Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization.

Hibah M Aldawsari1,2, N Raghavendra Naveen3, Nabil A Alhakamy1,2,4

  • 1Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.

Drug Delivery
|July 15, 2022
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Summary
This summary is machine-generated.

This study developed pulsatile ketorolac tromethamine tablets for arthritis morning stiffness. Optimized compression coating achieved a 9-hour lag time, enhancing drug delivery and bioavailability.

Keywords:
Compression coatingEudragit RLPOPEO WSR coagulantchronobiologyketorolac tromethaminequality by design

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Chronopharmaceutics

Background:

  • Pulsatile drug delivery systems are crucial for chronotherapeutic applications, aiming to release drugs at specific times.
  • Morning stiffness in arthritis necessitates drug delivery systems with a delayed onset of action to coincide with symptom peaks.
  • Ketorolac tromethamine is a non-steroidal anti-inflammatory drug commonly used for pain management.

Purpose of the Study:

  • To design and optimize pulsatile ketorolac tromethamine tablets using compression coating for delayed drug release.
  • To achieve a suitable lag time for treating arthritis-related morning stiffness.
  • To utilize Quality by Design (QBD) principles for robust formulation development.

Main Methods:

  • Formulation of rapidly disintegrating core tablets containing ketorolac tromethamine and super-disintegrants.
  • Compression coating of core tablets using polyethylene oxide (PEO) WSR coagulant and Eudragit RLPO for controlled release.
  • Optimization of formulation and process parameters (PEO WSR Coagulant, Eudragit RLPO, Hardness) using Central Composite Design and Response Surface Methodology.

Main Results:

  • The optimized pulsatile tablets exhibited a lag time of 9 hours and released 95% of ketorolac tromethamine in 17.42 hours.
  • Mathematical modeling and response surface analysis identified key formulation variables influencing lag time and drug release.
  • In vivo studies confirmed the desired lag time and enhanced bioavailability through targeted drug delivery.

Conclusions:

  • Compression-coated pulsatile ketorolac tromethamine tablets are effective for chronotherapeutic delivery, targeting morning arthritis symptoms.
  • The QBD approach successfully optimized the formulation, ensuring reliable lag time and controlled drug release.
  • This approach enhances drug bioavailability by aligning release with the body's natural rhythms.