To formulate and evaluate time dependent pulsatile drug delivery system of Montelukast sodium to deliver the drug with biological rhythm of asthma after predetermined lag time 5:30 hours. In preliminary study, The core tablet of Montelukast sodium was prepared by using direct compression method containing SSG, Croscarmellose sodium, Crospovidone, MCC and Starcap1500 to obtain fast disintegrating tablet for the selection of super disintegrating agent. PVAP, CAP and Ratio of Eudragit L 100: Eudragit S 100 was used as pH dependent polymer for coating the core tablets. Total 9 batches were formulated as per 32 full factorial design applied to check the effect of polymer ratio (Eudragit L 100: Eudragit S 100) and the effect of % weight gain on dependent variable lag time PRTs. These formulations were evaluated for physical parameters of tablet, drug -excipient compatibility study, lag time of rupture of PRTs and in-vitro drug release study. PDDS of Montelukast Sodium formulated using Croscarmellose sodium as super disintegrant and Eudragit L 100 and Eudragit S 100 as a coating polymers. Formulation M7 can provide site specific delivery with sigmoidal drug release.

I had studied development aspects of sustained release microspheres of Diclofenac sodium that release the drug Up to 24 hour and improve Bioavailability of Diclofenac Sodium by using spray drying and simple solvent evaporation technique.Preparation of Chitosan Microsphere with Diclofenac Sodium by various techniques such as spray drying and simple solvent evaporation technique. For Spry Drying technique the optimization of Spry Dried Parameter such as inlet Temperature and Feed pump Rate. Optimization of Temperature by taking the 130 degree C, as a starting Temperature and showing the Characteristic of Microspheres. Study Shows that the fine Partical were found in 150 degree C. Temperature, Feed Pump rate was also optimizes by this way and 2ml/min feed pump rate shows good Microspheres with higher %yield. So parameters were taken 150 degree C temperature and 2ml/min feed pump rate and Microspheres were Prepared. Further study with Drug to polymer ratio like 1:1,1:3 and 1:5 are carried out.As increase in the drug to polymer ratio from 1:1,1:3 and 1:5 the Entrapment efficiency was also increase and the release rate were Extended.

Oral drug delivery is the most widely utilized route of administration among the entire route that has been explored for the systemic delivery of drug via various pharmaceutical products of different dosage form. The conventional tablet seems to be most popular because of its ease of transportation and low manufacturing cost as compare to others but poor patient compliance with whom experienced swallowing difficulties. In response to this mouth dissolving drug delivery system (MDDs) were developed as an alternative to tablet, capsule and syrup. A variety of MDDs like Mouth dissolving tablets (MDTs) and Mouth dissolving films (MDFs) were commercialized. This book describes the design and development of sildenafil citrate mouth dissolving film. As sildenafil citrate is a widely utilized drug for erectile dysfunction. This produced mouth dissolving film prepared by newer polymer Kollicoat protect and showed the good alternative for the other mouth dissolving film former, specially HPMC. Stevioside a natural sweetener used and showed the potency to mask the bitter taste of sildenafil citrate. Hence, MDF of sildenafil citrate provide good alternate to other available dosage form.

Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteria's were considered.

In present research work, dispersible tablets of cefpodoxime proxetil were formulated using dry granulation technique. Cefpodoxime proxetil is an advanced-generation, broad-spectrum cephalosporin antibiotic. Cefpodoxime proxetil has slightly bitter taste and has poor water solubility. So in case of acute bacterial exacerbation of chronic bronchitis (AECB) groupA beta-hemolytic streptococcal pharyngotonsillitis, and uncomplicated skin/skin structure infections it require immediate release of drug from the dosage form, which make Cefpodoxime Proxetil suitable candidate for dispersible tablets.

The purpose of this study was to develop and evaluate a drug delivery system in vitro based on a compression coated tablet containing 5-fluorouracil (5-FU) in core and pectin Hydroxypropyl Methylcellulose (HPMC) mixture in coat layer. The main reason for selecting pectin was its biodegradation in colon by colonic flora. On other hand, high molecular weight HPMC increases mechanical strength of tablet coat around a drug core during its transportation in gastro-intestinal tract. Multiple regression analysis with two way ANOVA revealed that both factors had statistically significant influence for the response studied (P

Colorectal cancer is second leading cause of deaths in the United States. Various approaches available for The poor site specificity of pH dependent systems, because of large variation in the pH of gastrointestinal tract, was well established. The timed-release systems release their load after a predetermined period of administration. These are designed to resist the release of the drug in stomach and small intestine and release of the drug takes place in colon. Methotrexate (MTX) is a used in the treatment of colon cancer and now a days rheumatic disease. MTX is a folate antimetabolite. MTX has since been used in the treatment of various malignancies including osteosarcoma, non-Hodgkin's lymphoma, Hodgkin's disease, cutaneous T cell lymphoma, lung cancer, colon cancer and breast cancer. The conventional dosage forms which are used for colorectal cancer normally dissolve and absorbs in the stomach and small intestine; thus a very less quantity of dose of drug reaches to colonic region. Aim of present work is to develop and characterize colon targeted tablet of MTX for for treatment of colorectal cancer using different polymer and excipient by compression coating technology.

Levocetrizine hydrochloride is an oral antihistamine and antiallergic agent, which blocking histamine receptors. It does not prevent the actual release of histamine from mast cells, but prevents it binding to its receptors. This in turn prevents the release of other allergy chemicals and increased blood supply to the area, and provides relief from the typical symptoms of hey fever and rhinitus allergic condition. The dose of Levocetrizine hydrochloride ranges from 5 to 10 mg twice in a day and it undergoes extensive first pass metabolism. Hence it has only 66% bioavailability. The half life of the drug 8 to 10 hours indicates the need for modified release dosage form. levocetrizine hydrochloride was chosen as model drug with an aim to developed fast dissolving tablet that improve bioavailability, patient compliance and rapid action in rhinitus allergic condition.

The aim of this study was to develop a new intra-gastric oating in situ gelling system for controlled delivery of levetiracetam for the treatment of partial onset seizures.High dose of levetiracetam (750 to 1000 mg) is di cult to incorporate in oating tablets but can easily be given in liquid dosage form. Sodium alginate-based in-situ gelling systems were prepared by dissolving various concentrations of sodium alginate in deionized water, to which drug and calcium carbonate were added. A 32 full factorial design was used for optimization. The concentrations of sodium alginate (X1) and calcium carbonate (X2) were selected as the independent variables.The amount of the drug released after 1 h (Q1) and 6 h (Q6) and 12 h (Q12), viscosity and Floating lag time of the liquid formulation were selected as the dependent variables. The studies indicate that the formulation was effective in providing in vitro release for extended time up to 12 hrs and also convenient for geriatric and paediatric patient and increase drug residency to the GIT."

Venlafaxine Hydrochloride is an oral antidepressant agent of the Serotonin-Norepinephrine Reuptake Inhibitor class. Venlafaxine Hydrochloride has been studied for the treatment of panic disorder, post-traumatic stress disorder, and the treatment of hot flashes in patients who cannot or do not want to take hormone replacement therapy. The dose of Venlafaxine hydrochloride ranges from 75 to 225 mg three times a day and it undergoes extensive first pass metabolism hence it has only 45% bioavaibility. The short half life of the drug 5 hr indicates the need for modified release dosage form. Venlafaxine HCl was chosen as model drug with an aim to developed mucoadhesive buccal tablet that minimize dose related side effects and reducing the dosing frequency of drug and finally improve the bioavaibility.

The aim of present research work is to develop single pulse pulsatile release tablets that release Lornoxicam instantly after the lag time of about 5 hour which can be used for treatment of rheumatoid arthritis where symptoms are at their prime in the morning hours. Such a pulsatile release tablet of Lornoxicam taken at bed time and release the drug in early morning, thus enhance patient compliance. From various approaches erodible compression coating system is selected for the formulation of pulsatile release tablets, in which outer coating containing mixture of hydrophilic polymer (sodium alginate) and hydrophobic polymer (ethylcellulose). The release profile of compression coated tablet exhibited lag time followed by burst release, in which outer shell break into two halves.

Metoprolol Tartrate is a -blocker drug indicated for the treatment of angina, prevention of myocardial infarction, Essential hypertension; It has low bioavailability of about 40% due to hepatic metabolism. The purpose of this research was to improve the bioavailability by preparing a fast dissolving tablet using superdisintegrants method. Because pregastric absorption of drug improves bioavailability, gives rapid onset of action when needed."

The present research work is to design and evaluate an oral time dependent, pulsatile drug delivery system containing Salbutamol Sulphate, which can be targeted to time dependent manner, to modulate the drug level in synchrony with the circadian rhythm of nocturnal asthma. A time dependent pulsatile dosage form was developed by using a various grade of HPC in compressed coated layer. A pulsatile 'Tablet in Tablet' dosage form, taken at bed time with a programmed start of drug release early in morning hours, can prevent a sharp increase in the incidence of asthmatic attacks, during the early morning hours (nocturnal asthma), a time when the risk of asthmatic attacks is the greatest.