Research Journal of Pharmaceutical Dosage Form and Technology

S. A. Hapse ¹, B. V. Bhagat ¹, V. S. Wagh ¹, P. T. Kadaskar ¹

Affiliations
1 Department of Quality Assurance Technique, Padmashree Dr. Vithalrao Vikhe Patil College of Pharmacy, Ahmednagar, Maharashtra. 414111, IN

Abstract

Cross contamination is one of the major problems focused in manufacturing of drugs utilizing common facility which leads to inferior quality of final product and cause considerable loss to the company. Contamination of one batch product with significant levels of residual active ingredients from a previous batch and contamination by microorganisms are the real concern. Cleaning and decontamination is one of the major and critical activity in pharmaceutical operations. The concept of purity and safety are directly related to the cleaning operations. Cleaning programmers are necessary simply to prevent our manufactured products from being contaminated. These are cross-contamination of one product into another , product contamination by a foreign material and microbial contamination The cleaning validation is a documented process that proves the effectiveness and consistency cleaning of pharmaceutical equipments to meet the regulatory requirements. Manufacturing of paracetamol and other tablets utilizing common facility, where paracetamol could be a possible cross contaminant. Hence the present study was carried out to validate the cleaning activity from both regulatory and quality prospective. Visual inspection, Swab sampling for chemical residue and for microbiological analysis were carried out to validate cleaning activity and results from all methods were complying with acceptance criteria.

Keywords

Paracetamol, Sodium Lauryl Sulphate, Cross Contamination, Cleaning Validation.

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S. A. Hapse ¹, K. N. Tarkase ¹, A. S. Jadhav ¹, U. S. Dongare ¹

Affiliations
1 Padmashree Dr.Vithalrao Vikhe Patil Foundation’s College of Pharmacy, Vilad Ghat, MIDC, Ahmednagar (MS)-4141 11, IN

Abstract

Dosage form used to deliver drug via lungs can be used to treat asthma, COPD, or Diabetes, For formulation of such dosage form require dry powder with very short list of expedients such as stabilizer, solubilizer, property modifier ( flow enhancer ) For which different secondary processing parameter are been carried out such as milling , spray drying, lyophilization. Now in today market different type of container are been packing for dry powder inhaler there are also been different evaluation test for the DPI.

Keywords

Meter Dose Inhaler, Lyophilization, Control Release, Aerosol.

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S. A. Hapse ¹, K. N. Tarkase ¹

Affiliations
1 Padmashree Dr.Vithalrao Vikhe Patil Foundation’s College of Pharmacy, Vilad Ghat, MIDC, Ahmednagar (MS)-4141 11, IN

Abstract

Documented evidence with a high degree of assurance that a process will consistently produce product, meeting its predetermined quality attributes is nothing but a process validation. In short process validation is checking of reproducibility of result. The critical process parameter was identified and evaluated by challenging its lower and upper release specification. The three process validation batches (PVB1, PVB2, PVB3) of same size, method, equipment and validation criteria was taken. The critical parameter involved in blending, compression, coating for our Ranitidine tablet were identified and evaluated as per the validation master plan. From the result we have found that in the same environmental condition there was no significant batch to batch variation and all the parameter studied were in accordance with the BMR.

Keywords

Ranitidine Hydrochloride Tablet, Process Validation, BMR.

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