1. Dexibuprofen enteric film-coated tablets: design, characterization and pharmacokinetic analysis in human volunteers.
- Author
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Hanif, Anas M., Rehman, Abdul, Bushra, Rabia, Aslam, Nousheen, Alam, Shazia, Dawaba, Hamdy M., Dawaba, Aya M., and Sayed, Ossama M.
- Subjects
PATIENT safety ,TALC ,BIOAVAILABILITY ,PHARMACOKINETICS ,VOLUNTEERS - Abstract
Objective: This study aimed to develop a stable and scalable enteric film-coated tablet for the gastric irritant dexibuprofen. Methods: Utilizing direct compression with super-disintegration (crospovidone), the optimal core batches were coated with Opadry white seal coat and enterically coated with Eudragit
® L100 with pigment (Talc), demonstrating a 12% weight increase; release and integrity were assessed using specific pH buffers and SEM, with stability testing confirming a six-month shelf life at 40 °C and 75% RH. Results: The optimized formulation achieved 99.87% release in phosphate buffer within 60 min, maintained integrity for 120 min in acidic conditions, and exhibited superior bioavailability compared to Innovifen with relative bioavailability ≈of 121% and elevated Cmax (18.35 µg/ml compared to 11.1 µg/ml). Conclusion: These results highlight the potential of this formulation to enhance patient safety and efficacy through delayed enteric technology and fast intestinal release. [ABSTRACT FROM AUTHOR]- Published
- 2024
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