处方工艺研发报告模板-vitamin B 片剂

DEVELOPMENT OF THE PRODUCT

(STUDY OF PREFORMULATION OF THE PRODUCT) OBJECTIVE

To Obtain tablets of Vitamin B complex tablets that complies with National standard. SELECTION OF MATERIAL

Selection of Active ingredient

1.Thiamine Hydrochloride

Manufactured in Hubei Huazhong Pharmaceutical Co., Ltd. and complies with British Pharmacopoeia 2007. Thiamine hydrochloride is a white or almost white, crystalline powder, freely soluble in water, soluble in glycerol, slightly soluble in alcohol.

2. Pyridoxine Hydrochloride

Manufactured in Zhejiang Tianxin Pharmaceutical Co., Ltd. and complies with British Pharmacopoeia 2007. Pyridoxine Hydrochloride is A white or almost white, crystalline powder, freely soluble in water, slightly soluble in alcohol. It melts at about 205 °C, with decomposition.

3. Cyanocobalamin

Manufactured in Sichuan Pharmaceutical Co., Ltd. and complies with British Pharmacopoeia 2007. Cyanocobalamin is A dark-red, crystalline powder or dark-red crystals, sparingly soluble in water and in alcohol, practically insoluble in acetone. The anhydrous substance is very hygroscopic.

Selection of excipients

Below are reviewed in the formula selection: Maize starch, Sucrose, Dextrin, Hipromellose, Magnesium Stearate and Microcristalline Cellulose. All the ingredients complies with Bp or USP standards.

Selection of coating material

Thiamine hydrochloride, Pyridoxine Hydrochloride and Cyanocobalamin are hygroscopic, so we select the film coating material to protect the active ingredients. Coating the tablets use the film coating powder manufactured by Zhejiang Xinhua Pharmaceutical Co., Ltd. and Tianjin ILE Pharmaceutical Materials Co., Ltd.

Coating as normal according to the film-coating technics

Coating solution 1: manufactured by Zhejiang Xinhua, add into Purified water, agitate

45 minutes to prepare 8% coating solution.

Coating solution 2: manufactured by Tianjin ILE, add into Purified water, agitate 45 minutes to prepare 12% coating solution.

Test:

Heat-resistance test of coating film: tranfer tablets coated by solution 1 and solution 2 respectively into 80 oven for 3 hours, take out and observe the film change quickly. Moisture proof, water proof test . Separate put the tablets 20 tablets coated by the two coating solution under the circumstances of 25ºC RH75% and 25ºC RH92.5%, sample termly, weigh, calculate the moisture absorption.

Tablets 5 Results of moisture proof, water proof test

Percentage of moisture absorption %

Coating RH75% RH75% RH75% RH92.5% RH92.5% RH92.5%

Material 3 days 5 days 10 days 3 days 5 days 10 days

Solution 1 1.85 1.92 2.25 3.24 3.85 3.94

Solution 2 2.44 2.63 2.94 3.96 4.55 5.13

Dissolution test: For each type of the coated tablets, carry out the dissolution test respectively with 6 tablets, calculate the cumulated dissolution percentage.

Table 6 Results of dissolution test

Time min Percentage of cumulated dissolution % Ingredient

Coating Solution 1 Coating Solution 2

45 minutes 93.25±0.57 92.87±0.59 Thiamine 45

minutes 93.12±0.74 93.23±0.81 Pyridoxine 45 minutes 90.02±0.85 89.44±0.82 Cyanocobalamin

Conclusion coating solution 1 gives better performance in aspects as heat.resistance, moisture proof, water proof and dissolution of Cyanocobalamin, and tablet tablet

surface is more smooth and uniform. So we adopt the coating solution 1, that is 8%

coating solution, powder manufactured by Zhejiang Xinhua Pharmaceutical Co., Ltd. According above stated, we confirm the formula and manufacture process of Vitamin B complex tablet

1.3 Process validation