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Design of Experiments for Pharmaceutical Formulation Development

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Mr.Kirupakar .B.R

Mr.Kirupakar .B.R

Design of experiments (DOE) is a useful tool for determining specific factors
affecting defect levels in a product.

During the
1920s, a British statistician named Ronald Fisher put the finishing touches on
a method for making breakthrough discoveries. Some 70 years later, Fisher's
method, now known as design of experiments, has become a powerful software tool
for engineers and researchers.

But why did it take engineers so long to
begin using DOE for innovative problem solving? After all, they were ignoring a
technique that would have produced successes similar to the following
modern-day examples:

Today's Publication

Study of Formulation Variables on Properties of Drug-Gellan Beads by Factorial Design

sachinpatil79's picture
Submitted by sachinpatil79 on Fri, 07/04/2008 - 12:39.

Publication Type:

Journal Article

Authors:

Sachin Patil, Sameer Sharma,Anagha Nimbalkar and Atmaram Pawar

Source:

Drug Development and Industrial Pharmacy, Taylor and Francis, Volume 32, p.315-326 (2006)

Keywords:

Low-acyl gellan; Calcium-gellan beads; Ionotropic gelation; Factorial design

Abstract:

ABSTRACT The aim of the present study was to obtain cross-linked
calcium-gellan beads containing diclofenac sodium as model drug, using
full 33 factorial design. Drug quantity, pH of cross-linking solution, and
speed of agitation were selected as variables for factorial design. The
resultant beads were evaluated by scanning electron microscopy (SEM),
percent yield, entrapment efficiency, micromeritic properties, swelling
and drug release studies. The drug-loaded beads were spherical with size
range of 0.85–1.8 mm. Percent yield and entrapment efficiency of various
batches were in the range of 86.48–98.28% w/w and 72.52–92.74% w/w,
respectively. Calcium-gellan beads containing diclofenac sodium showed
pH-dependent swelling and drug release properties. Swelling and drug
release were significantly higher in pH 7.4 phosphate buffer than 0.1N
HCl. The swelling ratio for beads was up to 22 and 3 for phosphate
buffer and 0.1N HCl, respectively. Cumulative diclofenac sodium release
from calcium-gellan beads was 12–35% in 0.1N HCl within 2 h, whereas
complete drug release was observed within 3–4 h in pH 7.4 phosphate
buffer.

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Today's Blog

Palliative care and Pharmacist- Part 4

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Submitted by praseengp on Fri, 07/04/2008 - 17:32.
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In the UK, the Government has recognised the importance of the pharmacist’s role and provides funding to hospices to enable them to purchase pharmaceutical advice. This advice, which may be provided by either hospital or community pharmacists, consists of individual patient prescription monitoring, recommendations for formularies, advice on medicines policies, discharge planning and the use of patients’ own drugs and advice on stock control and the safe storage, administration and disposal of medicines Many patients, especially towards the end of life, have their medicines administered over24 hours through a syringe driver. There is little published data available on the compatibility of different injectable medicines in a syringe driver and pharmacists are often asked for professional advice on the stability and suitability of combinations of two, three and even four drugs in a syringe.

3. Specific preparations and products

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What's New ?

FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare.

FDA Update on Potentially Contaminated Heparin

Submitted by Anonymous on Thu, 07/03/2008 - 20:59.
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Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recommendations on this continuing issue.

Heparin is an anticoagulant commonly used subcutaneously and intravenously in patients undergoing kidney dialysis, certain types of cardiac surgery and other procedures. It is also used in lock flush solutions to maintain the patency of IV catheters, and as a coating or ingredient in certain medical devices and diagnostic products.

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