The development of new drugs that combine active ingredients for the treatment hypertension is critically essential owing to its offering advantages for both patients and manufacturers. In this study, for the first time, detailed development of a scalable process of film-coated bi-layer tablets containing sustained-release metoprolol succinate and immediate-release amlodipine besylate in a batch size of 10,000 tablets is reported. The processing parameters of the manufacturing process during dry mixing-, drying-, dry mixing- completion stages were systematically investigated, and the evaluation of the film-coated bi-layer tablet properties was well established. The optimal preparation conditions for metoprolol succinate layer were 6 min- dry mixing with a high-speed mixer (120 rpm and 1400 rpm), 30-min drying with a fluid bed dryer, and 5-min- mixing completion at 25 rpm. For the preparation of amlodipine besylate layer, the optimal dry-mixing time using a cube mixer (25 rpm) was found to be 5 min. The average weight of metoprolol succinate layers and bi-layer tablets were controlled at 240–260 mg and 384–416 mg, respectively. Shewhart R chart and X¯ charts of all three sampling lots were satisfactory, confirming that the present scalable process was stable and successful. This study confirms that the manufacturing process is reproducible, robust; and it yields a consistent product that meets specifications.
Objectives: This study aims to evaluate the color fastness and study the skin irritation of a natural hair dye cream from Henna leaves. Materials and method: Nineteen experimental (F1-F19) are conducted using the D-optimal model to evaluate the cause-effect relations and evaluate the color fastness of hair dye cream. Three independent variables were selected for the survey namely Henna extract concentration (X1 includes 5%, 10%, 15%), pH of cream (X2 includes 6, 7, 8), hydrogen peroxide concentration (X3 includes 0%, 2%, 4%). Three dependent variables include color fastness after 1 washes (Y1), 6 washes (Y2) and 12 washes (Y3). Test for skin irritation hair dye cream was applied for rabbits. Results: the optimal parameters of hair dye cream were identified, which included Henna extract concentration of 10%, pH of 6, hydrogen peroxide concentration of 4%. The fastness property of the dye was observed to be very good even after washing 12 times and the absence of sensitivity or reaction on the skin. Conclusion: The results showed that the product has the ability to dye hair and is safe for the skin.
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