The idea for writing this basic HPLC book was probably born during the project sanctioned by University Grants Commission - Pune. This book was written as an updated reference guide for busy laboratory analysts and researchers. Topics covered include HPLC operation, method development and validation aspects. This book can serve as a supplementary text for students pursuing a career in analytical chemistry. It describes basic theories and terminologies for the novice and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. A reader with a science degree and a basic understanding of chemistry is assumed.

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.

Carvedilol has unique pharmacological profile. It blocks 1, 2, and 1 receptors, used in the management of hypertension and as an adjunct to standard therapy in symptomatic heart failure and also produces vasodilation. In the present study, an attempt has been made to improve drug concentration in the stomach by preparing gastroretentive floating microsphere of carvedilol phosphate to maintain drug levels within a desired range, reduce dosing frequency, Improve patient compliance, improve dissolution and at the site of absorption.Drug molecules presenting no difficulties in their solubility and/or absorption problems are good candidates for oral controlled release formulations but Obstacle may arise for many drugs related to their solubility and/or absorption that may be overcome by formulating Gastroretentive systems which prolong the gastric retention time, improves solubility and hence improves bioavailability for drugs that are less soluble in a high pH environment.

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.

The purpose of this research was to formulate tasteless complexes of Fexofenadine Hydrochloride with Kyron-134 and to formulate tasteless complex into fast-Dispersible tablets (FDT) for the treatment of allergic rhinitis & chronic idiopathic urticaria. Drug release from FDT in salivary pH was insufficient to impart bitter taste. Complete drug release was observed at gastric pH. The studies indicate that the formulation was taste masked drug can be formulated in to FDT with view to enhance patient compliance & to obtain faster onset action of the drug which would be advantageous in comparison to the currently available conventional forms. Formulations D-5 was found to be palatable with in vitro disintegration time of 20 s Dissolution studies showed complete release of D-5 within 30 min.

Itopride, a novel prokinetic agent is unique and different from the available prokinetics because of its dual mode of action and lack of significant drug interaction potential. Itopride is a newly developed prokinetic agent, which enhances gastric motility through both anti-dopaminergic and anti-acetylcholinesterage actions. It is best candidate for Gastro Esophageal Reflux Disease. Itopride 50mg can be given thrice in a day for Treatment of GERD. By developing the sustain release formulation of Itopride hydrochloride, the frequency of drug can be reduce to once only to obtain good therapeutic response. The prepared formulation is usually taken on an empty stomach about an hour before meals. Sustained release tablet of Itopride Hydrochloride was prepared by using combination of HPMC grade as matrix forming material. The influence of amount of Hydroxypropyl Methylcellulose K15M and Hydroxypropyl Methylcellulose K100M on release of Itopride hydrochloride was studied using Central composite design. The optimized Formulation FB7 had given prolonged drug release up to 24 hr. It also had desired drug release kinetics and it was found to be stable after 1 month at accelerated conditions.

Nicotinic acid (NA) as lipid lowering agent drug has not become a first-line treatment due to the strong side effect called flushing occurs when given in immediate release dosage form. The tablets were prepared by wet granulation method using HPMC K-15M, polymer as retardant and the prepared tablets of NA will remain intact up to 2 hrs in pH 1.2 due to Eudragit L 100-55 and its release is not only initiated but tact fully retarded up to 12 hrs and were found to be superior in physical properties, dissolution characteristics, and drug content uniformity. The drug release from the matrix tablet Fitted to the Higuchi model and Zero order release which indicates non-Fickian diffusion.N8 showed good similarity with theoretical profile of nicotinic acid. Excipients has significant effect on drug release, because DCP retarded the release due to hydrophobic nature, on the contrary MCC increased drug release for its swelling property and causing burst release, and lactose moderately affected drug release due to channeling action and hence causing drug release at desired rate and amount. The studies indicate that the formulation was effective in providing in vitro release for extended perio

Famotidine is histamine -H2 receptor antagonist. It has bioavailability of 40 to 45% and it has shorter plasma half life of 2.5 to 3.5 hrs. The effective treatment of erosive esophagitis and Zolinger-Elisons syndrome requires administration of 20 mg of Famotidine 4 times a day. A conventional dose of 20 mg can inhibit gastric acid secretion up to 5 hours but not up to 10 hours. An alternative dose of 40 mg leads to plasma fluctuations; thus a sustained release dosage form of famotidine is desirable. Direct access to the systemic circulation bypasses drugs from the hepatic first pass metabolism leading to high bioavailability. Moreover, the buccal route is easily accessible, has a good patient compliance and can be used in patients who can't swallow. Bilayer buccal tablet was prepared by using mucoadhesive polymer combination of Sodium CMC and Carbopol934P, by direct compression with backing layer of Ethyl cellulose. The optimized formulation F1 had given release of 102.57% in 8hrs and it had optimum swelling, mucoadhesive property and permeation from buccal mucosa. It also had desired drug release kinetics and found to be stable for the period of 1 month.

Tolperisone hydrochloride has a short elimination half- life and rapidly absorbed from gastrointestinal tract.2 If it is formulated by conventional tablets, it will require multiple daily administrations (2-3 times daily) which ultimately results into in conveniency to the patients and possibility of reduced compliance with prescribed therapy. Tolperisone HCl is more stable in acidic medium (pH > 4.5), and in alkaline medium (pH 4 to 7) tolperisone breaks down into 4-MMPPO and piperidine. Thus, the patient is exposed to an uncontrollable quantity of 4-MMPPO 2methyl-1-(4methylphenyl)-propanone]. Proposed are floating tolperisone tablets with the controlled release of the active substance tolperisone in the stomach at pH 1 to 2.

The objective of this study is to develop controlled porosity osmotic pump tablet of Verapamil Hydrochloride, which is an antihypertensive candidate, using Polyethylene glycol (PEG) 400 as pore former in Cellulose acetate semipermeable membrane and Mannitol as a osmotic agent which release drug for extended period of time (24 h) and drug release of optimized formulation is independent of pH and agitation speed with zero order release.

In the present investigation, solid dispersion of olanzapine has been prepared to improve its solubility. Further, using solid dispersion, mouth dissolving tablet was prepared to overcome the problem of swallowing. A Simplex Lattice design was applied using three factors, i.e. superdisintegrants like croscarmellose sodium(X1) crospovidone(X2), and sodium starch glycolate(X3) in tablet formulation. Disintegration time, Wetting time, Water absorption, T50 (Time required to 50% drug release) and Q10 (percentage of drug released in 10 min.) taken as responses. Solid dispersion showed significant enhancement in solubility of olanzapine. For mouth dissolving tablet, batch containing 5% croscarmellose sodium alone had minimum disintegration time (44 sec.) and faster drug release(T50: 40 sec) compared to other batches.

To develop sustained release matrix tablet of Tramadol HCl that deliver drug for 24 hr and to be taken once in a day. Drug having high solubility and relatively shorter half-life suggests its suitability for an extended formulation. If it is formulated by conventional tablets, it will require multiple daily administrations which ultimately results into inconveniency to the patients and possibility of reduced compliance with prescribed therapy. Also fluctuation in plasma drug concentration leads to exaggerated side effects, this all limitations can be minimized by adopting extended release formulation. To reduce the frequency of administration and to improve the patient compliance, Once in a day sustained release formulation is desirable. It describes the influence of the concentration of HPMC K4M, HPMC K15M and HPMC K100M on Tramadol HCl sustained release formulations using box-behnken design.These Polymers were selected as an independent variables. Drug release after 8 hr, 12 hr and 16 hr were selected as a dependent variables. Optimized formulation found by similarity and dissimilarity factor follow zero order kinetic with non-fickian diffusion as a drug release mechanism.