DOI: 10.21276/ajptr
Tue, 21 May 2019


Onkar J. Deshmukh1*, Swaroop R. Lahoti2, Vivek B. Rajendra3, Bhushan S. Gulecha1, Pavan Kumar Rawat1, Snehal A. kulkarni3


1. Sherya Life Sciences, B9/2, MIDC Wlauj, Aurangabad-431136

2. Y.B.Chavan College of Pharmacy, Dr.Rafiq Zakaria Campus, Rauza Bagh, Aurangabad-01.

3. JSPM’s Jayawantrao Sawant College of Pharamcy and Research, Hadapsar, Pune-28.



The objective of designing a dosage form is to achieve predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. In order to ensure quality of product various features are required, like chemical and physical stability, preservation against microbial contamination, uniformity of dose of drug, acceptability to users including prescriber and patient, as well as suitable packing, labeling, and validation. The present research work focused on prospective process validation for the gliclazide 40mg tablet. Tablet was manufactured by wet granulation method. Formulation of tablet using Maize Starch, Avicel Ph 102, PVP-K30, sodium starch glycolate, Purified Talc, Aerosil 200 and  Magnesium stearate. Uniformity of dry mixing is excellent in 10min because % RSD found to be 0.4267-0.9021%. Granulating agent was prepared of desired consistency. Drying time 30 min is sufficient to achieve LOD 2-3%. Evaluation parameter of sizing shows effective LOD, % fine, BD & CI. Lubrication stage uniformity was achieved with 10min because % RSD found 0.8320-1.032% and flow properties was satisfactory. Compression machines optimum speed (20RPM) was satisfactory for effective compression. Based on results at each of the stages for the specified parameters it is concluded that gliclazide tablets can be effectively prepared with the desired specification & reproducible quality standards.


Keywords: Prospective Validation, Gliclazide, Tablet.

[PDF]   Viewed: 3139   Downloaded: 500
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.



  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.


  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.


web counter
web counter