ABSTRACT

Objective: To develop and to perform process optimization of solid dosage form (Skeletal muscle relaxant) from lab scale to pilot scale. To do the following tests on newly formulated Cyclobenzaprine Hydrochloride tablet and do Weight variation test, Thickness test, Hardness test and Friability test. Method: Dry granulation is typically used in the manufacture of tablets if the formulation ingredients are too fluffy or too susceptible to flowability problems for direct compression to be a viable processing option and/or too susceptible to degradation from heat and/or moisture for wet granulation to be a viable processing option for densification. The process is sometimes chosen as an alternative to wet granulation when direct compression is not feasible not because wet granulation is not feasible but because the manufacturer is more experienced with dry granulation or to reduce processing time and/or equipment requirements to reduce costs. The direct compression method is used. Result: The formulation 5 (F5) - It passes the weight variation test, thickness test, hardness test and friability test mainly the formulation-5 with coating 2% give best results in the above tests. Conclusion: ? The prepared Cyclobenzaprine Hydrochloride tablet formulation 5 (F5-2%) passes the limits of weight variation test, thickness test, hardness test and friability test. ? So far the formulation-5 (F5-2%) coated 2% is the best one for the pilot scale production of Cyclobenzaprine Hydrochloride tablet 10mg. Keywords: Direct compression, Tablet coating, Weight variation test, Hardness test, Friability test, Uniformity of thickness, Dry granulation
Publication date: 01/05/21

https://ijbpas.com/pdf/2021/May/MS_IJBPAS_2021_5491.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.5.5491