The purpose of this investigation was to prepare a gastroretentive drug delivery system of famotidine. Floating tablets of famotidine were prepared employing two different grades of methocel K100 and methocel K15M by effervescent technique; these grades of methocel were evaluated for their gel forming properties. Sodium bicarbonate was incorporated as a gas-generating agent. The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, in vitro buoyancy and dissolution studies. The effect of citric acid on drug release profile and floating properties was investigated. The prepared tablets exhibited satisfactory physico-chemical characteristics. All the prepared batches showed good in vitro buoyancy. The tablet swelled radially and axially during in vitro buoyancy studies. It was observed that the tablet remained buoyant for 6-10 hours. Decrease in the citric acid level increased the floating lag time but tablets floated for longer duration. A combination of sodium bicarbonate (130mg) and citric acid (10mg) was found to achieve optimum in vitro buoyancy. The tablets with methocel K100 were found to float for longer duration as compared with formulations containing methocel K15M. The drug release from the tablets was sufficiently sustained and non-Fickian transport of the drug from tablets was confirmed.

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For some time now modified drug release has been studied and used extensively during the development of pharmaceutical drug products because of its advantages over immediate release formulations. As per the forecasting by Global Business Intelligence (GBI) research, the growth in oral drug delivery market will uplift in the coming years. Modified release drug products allow at least a twofold reduction in dosing when compared to a drug that is presented in a conventional immediate release form. Modified release drug products are designed to release active pharmaceutical ingredient over a longer duration of time; At least, longer than an immediate release (I.R) formulation. Many Pharmaceutical companies also utilize the proprietary advantages of Modified release formulations to extend the patent life cycle of commercial products thereby bringing in new business.

DoE is a structured, organized method for determining the relationships among factors affecting a process and its output. It has been suggested that DoE can offer returns that are four to eight times greater than the cost of running the experiments in a fraction of the time that it would take to run one-factor-at-a-time experiments. It is always important before beginning experimentation to determine the objective of an experiment, and this is no different with DoE. Identifying objectives helps focus a team on its specific aims (scientific understanding of the task/problem in hand) over a period of time. It also helps indicate what resources are and assists in managing expectations from a study's outcome. DoE studies in support of QbD are often a delicate balance between delivering defined, high-quality products and meeting predetermined time, labor, and financial constraints.

Floating matrix tablets of losartan potassium were developed with an aim to prolong its gastric residence time and increase the bioavailability of drug. Rapid gastrointestinal transit could result in incomplete drug release from the drug delivery system above the absorption zone leading to diminished efficacy of the administered dose. The tablets were prepared by wet granulation technique, using polymers Methocel K15 and Methocel K100 in combination with other standard excipients. Sodium bicarbonate was incorporated as gas generating agent. The effects of sodium bicarbonate and polymers on drug release profile and floating properties were investigated. It was found that viscosity of Methocel K15 and Methocel K100 along with sodium bicarbonate had significant impact on the release and floating properties of the delivery system. The decrease in the release rate was observed with an increase in the viscosity of the polymeric system. Polymer with high viscosity Methocel K100 was shown to be beneficial than low viscosity polymer Methocel K15 in improving the floating properties of gastric floating drug delivery system (GFDDS). The observed difference in the drug release and floating properties of GFDDS could be attributed to the difference in the basic properties of two polymers, Methocel K15 and Methocel K100 due to their water uptake potential and functional group substitution. The release mechanism were explored and described with zero-order, first-order and Korsmeyer-Peppas equations. The drug release profiles and buoyancy of the floating tablets were stable when stored at 40°C/75% RH for 6 months.DOI: http://dx.doi.org/10.3329/icpj.v2i1.12872 International Current Pharmaceutical Journal 2012, 2(1): 11-17

The main aim present work was to optimize fast dissolving tablet (FDT) formulation using response surface approach. The variables studied were sodium bicarbonate (X1), citric acid (X2), and superdisintegrant, Ac-Di-Sol (X3). The main aspect of present work was to develop FDT of Domperidone which possesses fast disintegration and high mechanical strength. It was found that the response was affected by all the three factors studied. The statistical models were successfully used to prepare FDT of Domperidone with fast disintegration (31.08 seconds) and adequate hardness (4.1 kg/cm(2)). Pharmacokinetic studies in rats showed statistically insignificant difference (p>0.05) between Domperidone fast dissolving tablet (DFDT) and market product. This concluded that optimized FDT is bioequivalent with the marketed formulation. The values of Tmax were found to be 0.5 h and 0.75 h for DFDT and reference product, respectively. Conditioned place aversion study was performed on Swiss Albino mice and the study showed the better anti emetic potency of optimized FDT in nauseated condition over market product (p<0.05). Thus, the present investigation conclusively demonstrates the potential role in terms of rapid disintegration and high mechanical strength.

The investigation was concerned with design and characterization of oral sustained release gastro retentive floating tablets of DiltiazemHCl in order to improve efficacy and better patient compliance. Present investigation was to formulate, evaluate and optimize gastro retentive tablet of DiltiazemHCl. This tablets released drug till 24 hrs due to floating mechanism of polymer s. Gastro retentive floating tablets were prepared by direct compression method using various proportions of polymersHPMC K4M, HPMC K100M,Carbopol 934, Ethyl cellulose, Xanthan gum along with Sodium bicarbonatethe sustained release behaviour of the fabricated tablets was investigated. Tablets were prepared by directcompretiontechnique.Formulation was optimized on the basis of acceptable tablet properties and in vitro drug release. The resulting formulation produced robust tablets with optimum hardness, consistent weight uniformity and low friability. All tablets but one exhibited gradual and nearcomplete sustained release for DiltiazemHCl (90-100%) at the end of 24 h. The results of dissolution studies indicated that formulation Dtz15 was found to be most successful as it exhibits drug release pattern very close to theoretical releas e profile. A decrease in release kinetics of the drug was observed on increasing polymer ratio.

Analytical methods plays vital role in the process of identification, separation and then quantification of chemical components in natural materials or synthetic materials based on their chemistry. The main purpose of the analytical method development and validation is to prove that proposed analytical method is accurate, specific, precise and robust in the pharmaceutical industry for analysis of a drug moiety. Analytical method development gives important information in the pharmaceutical industry, on the potency of a drug, the drug’s bioavailability, the drug’s stability and also its effects. The analytical method validation is essential for analytical method development and tested for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit and robustness. In summary, analytical method development and validation confirms that an accurate, precise and reliable potency measurement of a pharmaceutical preparation can be performed. Keywords: HPLC, HPTLC, UPLC, GC, MS, SOP