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ABSTRACT

The main objective of the present research work was to develop a bilayer tablet of famotidine (FMT) and diclofenac sodium (DS) in separate layers thus to maximize the efficacy of both drugs in combination for the effective treatment of joint pain. Famotidine layer was formulated as fast release layer and DS layer was formulated as sustained release layers. Composition of both the layers was optimized in a separate set of experiments and then formulated as bilayer tablet. The individual layers as well as the bilayer tablets were evaluated for in vitro dissolution behavior. Kinetic studies of an optimized (D10) batch of DS in both sustained release layer and as bilayer tablet has shown good linearity of regression coefficient 0.9773 (first order equation). The results reveal that an optimized immediate release layer (F5) of famotidine and a sustained release layer (D10) of diclofenac sodium might be suitable for the treatment of joint pain by sequential release of the two drugs in a bilayer tablet.

Key Words:- Bilayer tablet, Diclofenac sodium, HPMC K100M, Famotidine.

ABSTRACT

The aim of the present study was to develop nanoemulsion formulation of pioglitazone to enhance the water solubility as well as bioavailability of drug. Three formulations of O/W nanoemulsions were prepared by the high pressure homogenization method by using different oil and co solvents. Pseudo ternary phase diagrams were designed to pick up the actual desired concentration of oil and co solvents used to obtain the nanoemulsion region. The study recommended that nanoemulsion significantly enhanced the solubility of pioglitazone so that it simultaneously enhances the bioavailability of pioglitazone.

Key Words:- Pioglitazone, Nanoemulsion, High pressure homogenization.

ABSTRACT

The regulatory process to obtain marketing authorisations (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. Complex and evolving ad-hoc requests from reviewers must be proactively addressed to avoid costly delays or show-stoppers to local product launches. This article offers a pharmaceutical regulatory environment in LATAM, resulting from more than a decade of experience in a biotech company, to ensure successful global regulatory strategy. The quality, safety and efficacy data has its own importance in the registration dossier. The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market. Although the International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local MA applications, it is not necessarily required in its full length. Additionally, a significant amount of mandatory and highly country-specific documentation (related to infrastructure, legal documents, stability studies, labeling, etc) require strategic planning and allocation for successful and timely local approvals. Exhaustive identification of actual requirements can present challenges due to frequent changes in regulations, unclear expectations, etc. Having as much early visibility and command of the LATAM country-specific requirements and health authorities‟ (HAs) expectations will help the pharmaceutical industry to improve planning for global MA applications, optimally manage internal expectations, and most importantly give patients in the region faster access to therapies and better quality of life.

Key Words:- Marketing authorization, Latin America (LATAM), Emerging markets, Pan American Network for Drug Regulatory Harmonization (PANDRH), Certificate of Pharmaceutical Product (CPP), Chemistry, Manufacturing and controls (CMC).

ABSTRACT

The oral health care of persons with HIV/AIDS needs special care and attention in India. It is an established fact that oral manifestations of HIV could very well be the first signs and symptoms of HIV positive cases. A well trained unbiased mind with strategic dental practice is the need of the hour in screening these patients and establishing a safe dental treatment for the patients.This article aims at highlighting the role of a dentist and norms of infection control to be followed along with a brief mention of post exposure prophylaxis to proficiently manage the patients as well as protecting the safety and health of the dentist and his team of personnel.

Key words:- Oral health in AIDS, Infection control, Post exposure prophylaxis

ABSTRACT

A controlled release Pulsincap dosage form of Bosentan was developed for the treatment of pulmonary arterial hypertension (PAH), which lead to serious cardiovascular complications. The main objective of the present study is to enhance the bioavailability of oral controlled release by developed matrix mini-tablet formulations at a therapeutic dose containing 15.625mg of Bosentan in each mini-tablets. Four mini-tablets are equivalent to the dose of 62.5mg of Bosentan for 12 hours release. Various concentration of polymers such as Poly Ethylene Oxide, Eudragit RSPO, Guar Gum and Karaya gum were used for the development of matrix mini-tablets. Based on the results obtained after performing physicochemical characteristics, In vitro drug release and stability studies on all batches, among all formulations, MT16 containing Karaya gum at 40mg has shown best and satisfactory results. Hence, this formulation was considered as best and selected for further In vivo evaluations. The present study focuses only on in vivo studies performed on best formulation MT16. As the conclusion, it was obvious that the mini matrix formulations were able provide controlled release of Bosentan in Rabbits. Knowing that the Rabbits attained controlled release of drug, which was observed with the mini matrix tablets when compared to the control is expected to be even longer in humans. This would maximize absorption by allowing the slowly released drug in upper part of small intestine (i.e. the sight of absorption). The mini matrix tablets showed better bioavailability characteristic while comparing with a commercial conventional tablet containing 62.5 mg of Bosentan (Bosentas, Cipla Ltd., Mumbai) with higher mean AUC0-∞, Cmax and longer Tmax, however non significantly different.

Key Words:- Bosentan; matrix mini-tablets, Cmax, Tmax, Lambda_z, t½el.

ABSTRACT Diabetes is a complex and chronic illness characterized by hyperglycemia. Anti-diabetic agents become less effective overtime and are often associated with undesirable effects. Improvement in glycemic control through inhibition of sodium glucose co-transporter (SGLT-2) inhibitors is an attractive, insulin independent target for increasing glucose excretion via urine, resulting in reduction of glycated hemoglobin, fasting and postprandial plasma glucose in patients with Type 2 Diabetes Mellitus (T2DM). SGLT2 inhibitor dapagliflozin provides an alternative and an addition to existing therapies for the treatment of patients with T2DM. It is a stable, competitive, reversible and highly selective inhibitor of SGLT-2 with an insulin-independent mechanism of action. It has potential to reduce hyperglycemia by inhibiting glucose reabsorption in kidney. Dapagliflozin when used as monotherapy and as add-on with metformin, glimepiride, sitagliptin or insulin improved glycemic control and resulted in statistically significant (p<0.0001) reductions in HbA1c compared to placebo. In clinical trials incidence of adverse events after single and multiple doses of dapagliflozin did not appear to be dose-related. Multiple oral doses of dapagliflozin either alone or with metformin were found to be safe and well tolerated. In randomized controlled trials hyperglycemia occurred in similar proportion of patients in dapagliflozin and placebo group. Urinary tract and genital infections were reported more in dapagliflozin treated patients than placebo. Dapagliflozin was not associated with an increase in cardiovascular risk in T2DM patients. Dapagliflozin with its unique and complimentary action either alone or in combination with other antidiabetic drugs provide an important option for the management of T2DM.

Key Words:- Dapagliflozin, SGLT2 inhibitor, Diabetes, Hyperglycemia, Kidney.

ABSTRACT Oral Submucous fibrosis is a premalignant condition that has received considerable attention in the recent past because of its chronic debilitating and resistant nature. Various treatment modalities have been proposed for this condition including steroid injections and surgical interventions. In this study a medicinal and a non-medicinal treatment were compared for their effectiveness in treatment of Oral Submucous fibrosis. To evaluate the efficacy of oral lycopene therapy in patients with Oral Submucous fibrosis and compare with the effect with those patients who were administered therapeutic ultrasound with physiotherapy exercises.Thirty (30) patients who enrolled with signs and symptoms of Oral Submucous Fibrosis at Dr D Y Patil Dental College were included in the study. The patients were divided into 2 groups, Group A included 15 patients who were administered Lycopene and Group B, included 15 patients who were administered Ultrasound therapy. Parameters included to assess effectiveness of the two treatments were: mouth opening, burning sensation and tongue protrusion. Results showed that tongue protrusion and burning sensation improved to a greater extent in Group A (lycopene group) as compared to Group B (ultrasound group) .Mouth opening improved to a greater extent in Group B(ultrasound group),compared to Group A( lycopene group), but the difference was not statistically significant. Results suggest that lycopene in isolation can be used as the initial treatment modality of Oral submucous fibrosis to relieve burning sensation, but if used in conjunction with therapeutic ultrasound will improve oral opening. Key Words:- Oral submucous fibrosis, Lycopene, Ultrasound, Burning sensation.

ABSTRACT

Tourism has been a major social phenomenon of the societies all along. It is motivated by the natural urge of every human being for new experience, adventure, education and entertainment. Tourism’s importance, as an instrument for economic development and employment generation, particularly in remote and backward areas, has been well recognized the world over. It is the largest service industry globally in terms of gross revenue as well as foreign exchange earnings (The Eleventh Five-Year Plan (2007-2012).

Key Words: Tourism, Social phenomenon, Societies all along.

ABSTRACTDetermination of toxicity is usually an initial screening step in the assessment and evaluation of the toxiccharacteristics of all compounds. In the present study, acute and sub chronic oral toxicity of the ethanolic extract of Phallusiaarabica on albino rats were investigated. The objective of safety evaluation for acute toxicity testing was done as per standardguidelines of OECD. Twenty four hours acute toxicity was performed with a single dose of 2000 mg/kg and subchronicstudies with six sets of six albino rats receiving a dose ranging from 200-2000 mg/kg bw for 14 days. No mortality wasobserved even at a dose of 2000 mg/kg. Severe gross behavioral changes like irritability, tremor, labored breathing, staggeringand convulsion were noted at a dose of 1600 mg/kg body weight and above only. Hematological, serum biochemicalparameters of the liver and kidney were unaltered throughout the study indicating non-toxic nature of the extract. The result ofthe study suggests there is no obvious toxicity on treatment with ethanolic extract of Phallusia arabica.

Key Words:- Phallusia arabica, Toxicity, Acute, Subchronic, Hematology, Biochemical parameters.

ABSTRACT Mitragyna inermis is a medicinal plant found in Nigeria and has diverse ethno medical uses including epilepsy. The aim of this study was to evaluate the anti-convulsant activity of aqueous and ethanolic extracts of Mitragyna inermis bark. The anticonvulsant activity of the extracts was investigated by studying the effects on seizures induced by pentylenetetrazole and strychnine in albino rats. The aqueous and ethanolic extracts of Mitragyna inermis at doses between 62.5 and 500 mg/kg dose dependently increased the onset of clonic convulsion induced by pentylenetetrazol and strychnine. There was a statistical significant difference between the effect of the extracts (at 250 and 500mg/kg) and the negative control (p<0.05). The data obtained suggest that Mitragyna inermis possesses anticonvulsant property with ethanolic extract having a superior activity than the aqueous extract. The activity of the extracts was found to prolong the onset of pentylenetetrazole induced seizures much higher than the strychnine induced seizures. Therefore, the activity of the extracts may be due to the involvement of Gamma amino butyric acid (GABA). Key Words:- Mitragyna inermis, Convulsion, Pentylenetetrazole, Strychnine.

ABSTRACT The aim of the present research was to development of formulation & evaluation of Zidovudine oral Nanosuspension. Zidovudine is a potent in vitro inhibitor of human immune deficiency virus belongs to the category of anti-retro viral drug. Zidovudine has the short biological half life and poor bioavailability due to solubility problems. The solubility of Zidovudine in various solvents, surfactants and cosurfactants were checked to optimize the components of Nanosuspension. The Nanosuspension was formulated by using methanol as an organic solvents and water, as the anti-solvent. Poloxamer-188, HPMC K-30, Eudragit S 100, PVP K-30, used to be polymers, Tween-80 as a surfactant prepared by High pressure homogenization technique. The formulated Nanosuspension were subjected for various evaluation parameters like particle size & shape, drug content, SEM, zeta potential, viscosity, saturation solubility, In vitro release, treatment of kinetic data & stability studies. Particle size, polydispersity index and zeta potential of optimized formulation were found to be 826.5 d.nm, 0.283pdi, 4.79(mv) so it is the stable one .On the basis of in vitro release study the formulation F2 & F1has been shown the highest amount of drug release respectively 98.06%, 97.35% based on the n value 0.5240 it was follows the Non- fickian diffusion mechanism. The stability studies we also conducted in two different on room temperature and refrigerator temperature it showed that the refrigerator is the more suitable for storage of nanosuspension. These results demonstrate the potential use of Nanosuspension for improving the bioavailability of poor water soluble compounds like Zidovudine. Key Words:- Zidovudine; high pressure homogenizer; oral route of nanosuspension; SEM; zeta potential.

ABSTRACT Dental plaque is a complex microbial community that develops on the tooth surface embedded in a matrix of polymers of bacterial and salivary origin. Then dental plaques were prevented/ cure by using the lactobacillus sporogenes microorganisms. The present work aimed to develop the medicated chewing gums using directly compressible Pharmagum-S and various polymers such as dibutyl phthalate, polyvinyl alcohol, paraffin wax and PVP K-30. Fourier transform infrared spectroscopy was confirmed the absence of any drug- polymers interactions. Twelve formulations (F1-F12) of medicated chewing gum tablets were prepared by using the various concentrations of polymers. Finally forms into tablets by using Cadmach 16 station compression machine by keeping hardness between 1-2 kg/cm-2. The prepared medicated chewing gum tablets were evaluated for thickens hardness, weight variation, friability, drug content uniformity, buccal absorption tests and in-vitro drug release studies. Key Words:- Dental Plaque; Lactobacillus Sporogenes; Medicated Chewing Gum; In vitro drug release.

ABSTRACT Soil acidity lowers the yield and even its bioactive compounds like forskolin. Forskolin is an alkaloid and many other diterpenoids are present in the leaves, roots and oils in the inflorescence. It helps to increase an enzyme, adenylate cyclase which increases cyclic adenosine monophosphate cAMP which activates other enzymes. This causes several physiological and biochemical effects, such as: Inhibition of platelet activation, degranulation, raises contraction of heart muscles, relaxation of the arteries and insulin secretion etc. In the light of significance of C.forskohlii Briq and its bioactive compound “Forskolin”. Acid soil correction by flyash is important, because chromatographic analysis of C.forskohlii extracts from Brazil, Africa and India revealed different compounds in different quantity and quality. The unique survival method is shown in the figure 1 and 2 in the next page. Before we proceed for further discussion on C.forskohlii Briq, we must have and insight into the soil acidity, its amelioration by flyash for better results. Key Words:- C.forskohlii, Forskolin.

ABSTRACT Isolation of infective agents and knowing the sensitive antibiotics is a herculean task. When the site of infection is an inaccessible or is protected naturally by barriers, the mode and dose of drug to be delivered becomes more important. We have highlighted such an issue. Key Words:- Colistin, Intravenous, Intraventricular, Pseudomonas.

Peptic ulcer disease is a common condition that arises due to break in gastrointestinal lining due to either excess stomach acid production or blunted mucosal defenses. The disease most commonly involves distal oesophagus, stomach, duodenum, jejunum. In every year peptic ulcer disease affects 4 million peo¬ple around the world. This study was performed to assess the Prevalence of perforated peptic ulcer in stomach and duodenum along with clinical suggestion and treatment. This becomes a retrospective take a look at of the patients who admitted as an emergency. Our examine included all the patients who have been recognized with gastric perforated ulcer 70 patients. X-ray abdomen erect posture, leukocyte count, serum amylase were performed along with other investigations. After surgery, site of perforation type of surgery along with any complications and outcome of treatment were recorded. Patients were followed-up for 30 days.Out of the total of 70 patients studied, 59 were men, i.e., 84.2% while 11were women, i.e., 15.7%, with a men and women ratio of 5.36:3. Twenty nine cases (41.4%) had perforated gastric ulcer (P.G.U), 26 patients (37.1%) with perforated duodenal ulcer (P.D.U))and15 patients (21.4%) had a drug-induced ulcer (D.I.U). Men are extra usually affected with peak occurrence inside the thirties. Abdominal pain and vomiting are the 2 essential and early scientific predictors of the diagnosis and risk. Duodenum and pylorus are the most not unusual sites of perforation. A prompt, correct analysis and immediate surgical operation is of prime importance in patients with perforated peptic ulcers. The mortality fee increases with the duration of the interval among the time of the ulcer perforation and the time of the surgical treatment