Metformin hydrochloride has relatively short plasma half-life, low absolute bioavailability. The need for the administration two to three times a day when larger doses are required can decrease patient compliance. Sustained release formulation that would maintain plasma level for 8-12 h might be sufficient for daily dosing of metformin. Sustained release products are needed for metformin to prolong its duration of action and to improve patient compliances. The overall objective of this study was to develop an oral sustained release metformin hydrochloride tablet by using hydrophilic Eudragit RSPO alone or its combination with hydrophobic natural polymers Gum copal and gum damar as rate controlling factor. The tablets were prepared by wet granulation method. The in vitro dissolution study was carried out using USP 22 apparatus I, paddle method and the data was analysed using zero order, first order, Higuchi, Korsmeyer and Hixson-Crowell equations. The drug release study revealed that Eudragit RSPO alone was unable to sustain the drug release. Combining Eudragit with gum Copal and gum Damar sustained the drug release for more than 12 h. Kinetic modeling of in vitro dissolution profiles revealed the drug release mechanism ranges from diffusion controlled or Fickian transport to anomalous type or non-Fickian transport. Fitting the in vitro drug release data to Korsmeyer equation indicated that diffusion along with erosion could be the mechanism of drug release.

The overall objective of the present work was to develop an oral sustained-release (SR) metformin tablet prepared by the direct compression method, using hydrophilic hydroxylpropylmethylcellulose (HPMC) and Guar gum polymer alone and in combination at different concentrations. Metformin hydrochloride (HCl), a biguanide, has a relatively short plasma half-life and low absolute bioavailability. All the batches were evaluated for thickness, weight variation, hardness and drug content uniformity and in vitro drug release. Mean dissolution time is used to characterize the drug release rate from a dosage form, and indicates the drug release-retarding efficiency of the polymer. The hydrophilic matrix of HPMC alone could not control the Metformin release effectively for 12 h whereas when combined with Guar gum, it could slow down the release of drug and, thus, can be successfully employed for formulating SR matrix tablets. Fitting the data to the Korsmeyer equation indicated that diffusion along with erosion could be the mechanism of drug release. Similarity factor ƒ2 values suggest that the test and reference profiles are identical.

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The formulations consisting of a hydrophilic and hydrophobic material were investigated for effect on drug-release pattern from the matrices. Gum damar and gum copal being water-insoluble were used to study the efficiency of combined matrices to sustain the release of drug. Hydroxypropyl methylcellulose K100M and diclofenac sodium were used as the hydrophilic material and model drug, respectively. The influence of concentration of hydroxypropyl methylcellulose on drug release pattern of hydrophobic material was determined. The optimum ratio of drug: polymer was found to be 1:1. The hydrophobic:hydrophilic polymer ratio of 75:25 was found to have a similar release pattern as that of marketed formulation. At this ratio, the initial burst-release that occurred in individual hydrophobic matrices was lowered to a great extent. The release of drug was found to follow Higuchi's equation as the concentration of hydrophobic material was increased. The formulations were compared with marketed formulation Voveran SR, and a correlation was drawn accordingly.

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Conventionally, all the delivery systems have been prepared by methodology of trial and error concept by manipulating one variable at a Time, but attainment of optimal formulation is not achievable. The systematic approach Design of Experiments (DoE) enables researchers to provide appropriate outline to develop a best optimized delivery system. Optimization techniques using DoE helps to provide effective and economical analytical tools to find the perfect solution for a particular problem. In screening designs, there is large number of screening factors in minimum number of experiments and beneficial to minimize the variables in a desired size therefore further experimentation may be performed easily by using these variables. Experimental designs and optimization techniques are the tools which are systematically used to categorize various types of problems that may influence development of pharmaceutical delivery system. Use of experimental design is the best approach to the screening and optimization of experimental factors. In the present review article we have focused on application of practically applicable experimental designs and optimization techniques for the development of quality and efficacious of pharmaceutical formulations such as, nanoparticles, Phytosomes, microspheres, liposomes, micells, films, nanostructured lipid carriers and tablets and which type of factors to be considered while optimization are also discussed. Keywords: Experimental design, Optimization, Applications, Drug delivery, Phytosomes, Nano delivery System.