In addition, many joint diseases are associated with muscle spasms therefore, adding anti-muscle contraction (skeletal muscle relaxant) like baclofen could relieve patients’ musculoskeletal pain. 3, 4 Oral non-steroidal anti-inflammatory drugs have been associated with greater efficacy in the more severe knee and hip OA patients. Keywords: baclofen, meloxicam, co-processed excipients, orally disintegrating tablet, six sigma methodologyĪround 18% of women and 10% of men over 60 years are affected by osteoarthritis (OA), 1, 2 which is a musculoskeletal condition characterized by severe deterioration and loss of articular cartilage and usually accompanied by structural and functional changes in the whole joint. Pharmacokinetic study of the improved ODTs showed a significant decrease of T max to 120 and 30 min instead of 180 and 120 min for meloxicam and baclofen, respectively.Ĭonclusion: ODTs were successfully improved using the six sigma methodology, the pharmacokinetic parameters of both drugs were enhanced due to rapid absorption through the oral mucosa.
The current sigma level was 3.628 σ and 3.33 σ for palatability and solubility of ODT, respectively, which indicated the process was successfully improved compared with the previous sigma level of 2.342 σ of both processes. All the improved ODTs had a bitterness taste score vary from (0) palatable and (+1) tasteless. Results: Pharmaburst-based formula (F4) showed the shortest wetting time and, consequently, the shortest disintegration time and the highest percentage of drug dissolved within 3 min compared to the other formulae. Finally, a pharmacokinetic study of the improved ODT was accomplished in comparison to the conventional oral tablet. To enhance the in-vitro dissolution of meloxicam and palatability of ODT, a six sigma methodology was used, and an improvement phase was established where ODTs were prepared using lyophilization and levigation techniques. ODTs were evaluated according to weight variation, thickness, friability, hardness, drug content, wetting time, in-vitro disintegration time, in-vitro dissolution test, and palatability.
Methods: Direct compression method was used to prepare ODTs using three types of co-processed excipients (Prosolv ODT G2 ®, F-melt ®, and Pharmaburst ® 500). Purpose: This study aimed to formulate an orally disintegrating tablet (ODT) containing both baclofen and meloxicam together for treating osteoarthritis. Rehab Abdelmonem, 1 Menna M Abdellatif, 1 Inas Essam Ibrahim Al-Samadi, 1 Mohamed A El-Nabarawi 2ġDepartment of Industrial Pharmacy, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science and Technology (MUST), 6th of October, Giza, 12566, Egypt 2Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Giza, EgyptĬorrespondence: Menna M Abdellatif Tel +20 1005647945
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