DESIGN, FORMULATION AND ANALYTICAL METHOD DEVELOPMENT OF CYCLOBENZAPRINE AND PARACETAMOL TABLET
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Date
2022-09-25
Authors
Raghad Abd alraoof Lubbadeh
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Abstract
ABSTRACT
Background: Cyclobenzaprine HCl is a muscle relaxant, and Paracetamol is a pain relief drug. There are many indications for the co-administration of both medications. The aim of this project was to formulate and evaluate the stability of a novel tablet containing Cyclobenzaprine HCl and Paracetamol together. Moreover, a new fully validated and stability indicating HPLC method was developed to test the stability of the obtained product.
Method: The Cyclobenzaprine HCl and Paracetamol novel tablet formula was optimized and selected according to several critical quality attributes (CQAs), including assay, content uniformity, dissolution, and degradation profiles. Method development it’s validation included linearity and range, accuracy and recovery, precision, specificity and stress conditions. Moreover, tablet stability was evaluated after 3 and 6 months under different storage conditions. A pilot study was conducted among doctors and patients to evaluate their opinions and acceptance of this combination.
Results: Successfully formulated tablets, including 5 mg Cyclobenzaprine and 500 mg Paracetamol, were uniform in weight, with an average tablet weight of 650 mg. All product quality parameters were within specifications, including those for critical and non-critical quality attributes. A fully validated and stability-indicating method was established for assay and dissolution testing. The developed method exhibited high linearity with an R2 of more than 0.98 precision with a relative standard deviation of less than 2% and an accuracy result of between 98.0 and 102% for Cyclobenzaprine HCl and Paracetamol. The prepared Cyclobenzaprine HCl and Paracetamol tablets showed excellent stability over 6 months. The findings of the pilot field study provided insight into the acceptance of the combination of both drugs by doctors and patients.
Conclusion: Cyclobenzaprine HCl and Paracetamol tablets were successfully formulated and showed an acceptable stability profile. The developed and validated HPLC method was suitable for the characterization and assessment of the formulated tablets. The novel combination is likely to be accepted by doctors and patients.
Key words: Cyclobenzaprine, Paracetamol, Formulation, Validation, Tablets.