Formulation and Evaluation of Baclofen-Meloxicam Orally Disintegrating Tablets (ODTs) Using Co-Processed Excipients and Improvement of ODTs Performance Using Six Sigma Method

Abstract

Purpose: This study aimed to formulate an orally disintegrating tablet (ODT) containing both baclofen and meloxicam together for treating osteoarthritis. Methods: Direct compression method was used to prepare ODTs using three types of coprocessed excipients (Prosolv ODT G2 ® , F-melt ® , and Pharmaburst ® 500). ODTs were evaluated according to weight variation, thickness, friability, hardness, drug content, wetting time, in-vitro disintegration time, in-vitro dissolution test, and palatability. 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. Finally, a pharmacokinetic study of the improved ODT was accomplished in comparison to the conventional oral tablet. 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. All the improved ODTs had a bitterness taste score vary from (0) palatable and (+1) tasteless. 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. 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. Conclusion: 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.

Formulation and in vitro evaluation of pramipexole orally disintegrating tablets for pediatric restless leg syndrome

“…But the Ludiflash ® behaved similar to Parteck ® ODT, in spite of containing PVPP. Therefore, this result can be interpreted as the major of influence of co-processing type on SWTs of ODTs, as Pharmaburst ® 500 showed a very short SWT, which findings were in agreement with previous studies [37,38].…”

Design and optimization of silymarin loaded in lyophilized fast melt tablets to attenuate lung toxicity induced via HgCl2 in rats

“…The spectra for pure SM, plain F7 and F7 were done separately by blending each sample with KBr at a ratio of 2:200, and the samples were directly loaded into FT-IR (IRAffinity-1, Shimadzu, Japan) (ElMeshad et al., 2020 ; Naveen et al., 2020 ; Sheta et al., 2020 ; Abdelmonem et al., 2021 ; Song et al., 2021 ) in the frequency range 4500-500 cm −1 .…”

“…Group III: rats received mercuric chloride (1 mg/kg) + F7 (100 mg SM/kg) for 15 days; F7 tablets were cut into pieces and allocated in the oral cavity of the rats by using forceps followed by administration of 20-50 microliters of water to enhance disintegration (Abdelmonem et al., 2021 ).…”

Measurement of Process Capability of Manufacturing Process of Levetiracetam by Applying Concept of Six Sigma

“…Literature survey revealed that there was no analytical method for measurement of the process capability of six sigma on levetiracetam tablet. This revealed that there was an analytical method to measure process capability of six sigma on various drugs like Ranitidine, 11 Antihypertensive tablet, 12 Baclofen-Orally Disintegrating Tablets (ODTs), 13 Oral Solid Dosage Case Study, 14 Metformin Hydrochloride, 15 Cefdinir and Sodium Benzoate, 16 Omeprazole Capsules, 17 Amlodipine Tablet, 18 Ibuprofen Tablet. 19…”