ABSTRACT

In this study work a comparative and differentiation has been put forwarded to make some recommendations of the regulatory framework. Now a day’s it’s too hard to invent a new drug so, the major pharmaceutical companies mainly depend up on the generic production of drugs. The generic drugs are very cheap when compared to innovator drugs in production cost and these generic products are customer friendly. . In this study the information was extracted from certain journals, text books, and related websites and from the authorized regulated authorities of the particular countries. The Topics covered in this study are introduction to regulatory affairs as well as regulated authorities in USA, CANADA and EUROPEAN UNION. About the data exclusivity and patent protection term information and the comparison among USA, CANADA and EUROPEAN UNION are enlisted in this topic. The comparison between the number of NDA approvals and ANDA approvals of USA, CANADA and European Union are represented statistically from 2006 to 2013 are labeled. The number of total molecule wise approvals in these countries is represented through pie charts and the top most pharmaceutical firms and their brand names of inhalation and nasal products are mentioned.

Keywords: Nasal Products, NDA, MAA.

ABSTRACT

This topic aims at reviewing the drug filing and different aspects of obtaining United States Food & Drug Administration (USFDA) and European Medicines Agency (EMA) approval for a drug in order to get a Marketing Authorization in US &Europe and their effective role in improving the standards laid down by them. The goal of the approval process is to provide enough information about the drug safety and efficacy in human beings. ANDA is a regulatory submission for authorization of generic version of New Drugs after expiry of its patent period in US. Marketing authorization application is filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human use (CHMP)) to market a drug or medicine. In Europe there are four types of marketing authorization procedures like national procedure (NP), centralized procedure (CP), decentralized procedure (DCP) and mutual recognition procedure (MRP) for getting generic drug approval process. The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, and the United States. Quality, Safety and Efficacy information is assembled in a common format through CTD.

Keywords: Generic drugs, drug approval process, ANDA, MAA, CTD format.

ABSTRACT

H. pylori is a gram- negative, microaerobic bacterium with a worldwide distribution in the acid –secreting gastroduodenal mucosa of man. H. pylori colonization itself is not a disease, but infection causes various clinical disorders in the upper gastrointestinal tract. Combination antibiotic therapy is advocated as its first line of treatment. But development of resistance to antibiotics, undesirable side effects and significant cost of the therapy makes it very difficult for the effective management of the condition. Moreover, compliance with the antibiotic regimen which is usually administered for 14-21 days is a big hindrance to the successful management of H. pylori. The need of the hour is to search for an alternative natural therapeutic agent which should be cost effective, devoid of undesirable side effects and must be easily available to the common people. Recent studies have suggested that H. pylori infection can be suppressed through the use of medicinal plants. In this context, recent research study reports reflect that gastro-protective medicinal plants as described in Ayurvedic Texts like Sunthi (Zingiber officinale), Rasona (Allium sativum), Kampillaka (Mallotus philipinensis), Kalajaji (Nigella sativa), Chitraka (Plumbago zeylanica), Sarpunkha (Tephrosia purpurea), Haridra (Curcuma longa), Amragandhi Haridra (Curcuma amada) and Twak (Cinnamomum spp.) possess significant anti- Helicobacter pylori activity. Therefore, it is concluded that inclusion of natural antioxidants in the normal, daily diet may be the best remedial measure for continued protection from H. pylori infection. They are nontoxic in nature and hence can be used safely.

Keywords: Helicobacter pylori, peptic ulcer, Ayurveda

ABSTRACT

Bars (Vitiligo) is a disease that was observed very early in history and most ancient civilizations and religions had some references about lack of pigmentation. The knowledge on aetiopathology of Bars is ambiguous and the treatment is very difficult till date. Wide range of literature is available in classical Unani system of medicine. Keeping in view, this review is focused on the aetiopathology and treatment of bars.

Keywords: Bars; Vitiligo; Unani System of Medicine; Quwat-e Mughaiyirah

Abstract

Medical Laboratory diagnosis begins with qualitative urine analysis using a random voided urine for micro, sugar and albumin to diagnose symptoms associated with infection, diabetes and renal failure.  Quantitative analysis using blood is the method of choice and once autoanalyser evolved, laboratories started using urine for quantitative analysis.  Biochemistry plays a significant role in the quantitative measurements of metabolites and its end products excreted in urine to correlate their levels in blood.  The other body fluid used for laboratory diagnostic purpose are saliva and sweat. Saliva and urine based biochemical tests are emerging as latest trends in laboratory diagnosis. The diagnostically useful tests using urine as specimen are TB-LAM to confirm TB, Fibrinopeptide A for ovarian and Gastric Cancer and Apo A1,A2, E and α1 antitrypsin for bladder cancer. This paper is an attempt to bring out the latest research findings in the use of urine for quantitative measurement of various analytes and its clinical usefulness.

Keywords: Urine, TB-LAM, Apolipoproteins, Bladder Cancer

ABSTRACT

Smoking has a distractive impact on human health that greatly influences the chance of developing stroke. In India, the third top risk for health loss is the smoking that leads to approximately 1 million deaths every year. Smoking is the main cause for 10% of the stroke deaths. The risk of stroke will be double due to smoking. According to a recent Indian study, smoking is the third most common cause of stroke. When compared to non smokers, smokers are three times more likely to have a stroke. Usually a stroke can be caused by interruption of blood supply to the brain due to the blockade by a clot or burst of the blood vessel. When compared to the non smokers and non hypertensive patients, a smoker with hypertension is 15 times more prone to have a subarachnoid hemorrhage. Second hand smokers were twice likely to have a stroke when compared to the persons who work or live in a non smoking atmosphere. There is an increased chance of having stroke for the non smokers who were married to smokers. The best way to prevent to stroke is to quit the habit of smoking. At present, for quitting the habit of smoking various supportive measures were available that includes group therapy, counseling, nicotine replacement therapy and help line support. Deaths due to smoking can be escapable and preventable by complete cessation of smoking. Quitting the habit of smoking reduces the risk of stroke significantly.  Awareness should be created regarding the health risks associated with smoking and the benefits associated with the cessation and prevention of smoking which helps in reduced health costs on the society to live in a healthy environment.

Keywords: Smoking, Smoker, Non- Smoker, Stroke.

ABSTRACT

The repellent activity of methanolic extract of flower buds (clove) of Syzygium aromaticum Linn. and its different fractions was screened against the dengue fever and yellow fever mosquito, Aedes aegypti L. at 4% concentration under laboratory conditions using human subject. The extract and main ethyl acetate soluble fractions were the most effective and showed 80% repellency for 4 hours while petroleum ether soluble sub-fraction of latter fraction gave 72% repellency for 4 hours. These samples were 50-60% effective for 9 hours. The results were compared with standard mospel. Furthermore, in the present investigation toxicity of the extract and fractions of clove was determined against 4^th instar larvae of Ae. aegypti by using WHO method. The extract, ethyl acetate soluble main fraction and petroleum ether soluble sub-fraction showed mortality with LC₅₀ 320, 240 and 160 ppm, respectively after 24 hours of exposure. It was observed that toxicity decreased with the increasing polarity of the fractions. These results were compared with standard neem formulation, biosal showing LC₅₀ = 400 ppm against the same mosquito Ae. aegypti.

Keywords: Syzygium aromaticum, Clove, Aedes aegypti, Mosquito repellent, Larvicidal.

ABSTRACT

This study was carried out to evaluate the effects of Annona muricata ethanolic leaf extract on the testes of adult wistar rats. Twenty wistar rats weighing between 180 – 205g were used for the study. They were designated into four groups (A, B, C & D) of five animals each. Group A animals served as the control and were orally administered 0.3ml of distilled water; the experimental groups B, C & D were orally administered 0.2 ml, 0.4ml and 0.6ml of Annona muricata ethanolic leaf extract respectively for twenty eight days. Twenty four hours after the last administration, the animals were weighed, sacrificed under the influence of chloroform vapour and dissected. Testes tissue were removed, weighed and fixed in 10% formalin for histological studies. The final body weight of groups C and D decreased significantly (P<0.001) compared with the control. The relative organ weight of groups C and D increased significantly (P<0.001) compared with the control. The mean relative organ weight of group B was statistically similar with the control. Histological findings revealed necrotic changes in the interstitial tissue, loss of spermatide changes and multinucleated giant cells in group C and D. From these findings, Annona muricata ethanolic leaf extract administered in high doses may cause histopathological alterations/lesions in the testicular cells.

Keywords: Annona muricata, Body weight, Organ weight, Wistar rats, Spermatide.

ABSTRACT

A popular group of nitrogen containing heterocyclic compounds, pyrazoles and pyrazolines [dihydropyrazoles] have been extensively studied. These compounds are easy to synthesize and moreover different moieties can be introduced in the hetero system with suitable reaction conditions. The biological activity that has been investigated include antibacterial, antimicrobial, antimalarial, antifungal, antitumor and anticancer amongst several others. Among all the pyrazolines, 2-pyrazolinehave gained maximum attraction and is the most frequently studied one. Pyrazolines, synthesized from chalcones, have also been studied extensively for cytotoxicity. In the present work some novel 2-pyrazoline derivatives have been synthesized and characterized. For the synthesis conventional as well as non-conventional methods has been adopted and a comparative analysis has been studied.

Keywords: Pyrazolines, synthesis, conventional method, non-conventional method, characterization.

ABSTRACT

The plant Acacia leucophloea has been traditionally used for several medicinal purposes. The present study is an attempt to explore antimicrobial activity, antioxidant activity and to analyse medically active compounds both qualitatively and quantitatively from leaves of plant Acacia leucophloea by using hexane, acetone, methanol and water as solvents. The extracts were evaluated for their antibacterial and antifungal activities on human pathogens and in-vitro antioxidant activity of Acacia leucophloea was determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) free radical scavenging and reducing power assay. Ascorbic acid is kept as standard reference and positive control for both the analysis.The total phenol content was determined by the Folin Ciocalteu procedure. Our investigations revealed that only methanol extract showed significant antimicrobial activity against all pathogen, whereas acetone and aqueous extracts showed better inhibitory action and hexane extract showed low antimicrobial activity against tested pathogens. The aqueous extract of Acacia leucophloea showed good antioxidant activity and methanolic extract has comparatively high phenolic content. It can be concluded that the extracts of Acacia leucophloea has good anti-microbial, antioxidant activities and finally we suggest that Acacia leucophloea leaf extracts are rich in bioactive compounds and have good biological activities. However, further detailed investigations are needed to ascertain the mechanisms and constituents behind its biological actions.

Keywords: Acacia leucophloea, anti-oxidant, Anti- microbial, Phytochemicals.

ABSTRACT

Ultraviolet-B radiation affects the surface layer of the skin mainly Keratinocytes which leads to harmful biological disorder. This study explored the effect of Methanolic extracts of Fish Mucus (FME) from parrot fish Scarus ghobban against UV-B radiation treated Cultured Human Keratinocytes (HaCaT). HaCaT cells treated with FME for 24hrs followed by UV-B irradiation for 15mJ/cm². After the irradiation, the HaCaT Cells were assayed for IL-2 cytokine. UV-B radiation induces an increase in cytokines, when ti is incorporated with the FME the concentration of cytokines reduced to normal. This study reveals that FME may be a photoprotective agent.

Keywords: Keratinocytes, UV-B, FME.

ABSTRACT

Preeclampsia is a metabolic syndrome and a major cause of maternal, fetal and neonatal morbidity and mortality that amounts to 10% of the pregnancy complications. To determine Malondialdehyde, protein carbonyl and total antioxidant status in preeclampsia and normal pregnant women during pre and post labour within 48 hours. A prospective case control study (n= 60), preeclampsia (n=30) and normal pregnant women (n=30) during pre and post labour within 48 hours. 3 ml of blood samples were collected during pre and post labour of normal pregnant and preeclampsia. MDA, Protein Carbonyl Content and Total Antioxidant Status were measured using spectrophotometric method. Mean ± SD were determined by using student “t” test. The Mean ± SD values of MDA µmol/L (4.7 ±1.8), Protein Carbonyls (168.9±70.5) nmol/, Total Antioxidant Status mmol/L (537 ± 451) in normal pregnant during pre-delivery and  MDA µmol/L(2.4 ±0.1), Protein Carbonyls (169±67.2)nmol/L , Total Antioxidant Status mmol/L (634.3 ± 241.2)  post-delivery presented. Similarly Mean ± SD values of MDA µmol/L (10.1 ±6.4), Protein Carbonyls (159±123.2)nmol/L , Total Antioxidant Status mmol/L (506.7 ± 287.6) in preeclampsia pre delivery and (6.1±6.1), (98.8±36.8), (680±362.3) post-delivery respectively. A well-known aspect in preeclampsia with increased concentrations of oxidative stress and decreased TAS. However the trend of increased TAS and declined oxidative stress during post labour of normal pregnant and preeclampsia which plays a significant role in pathophysiology of preeclampsia.

Keywords: Preeclampsia, Before delivery, After delivery, Protein carbonyl content

ABSTRACT

The purpose of this investigation is to prepare and evaluate colon specific microspheres of indomethacin for the treatment of colorectal cancer. sodium alginate microspheres are prepared by ionotropic gelation method using different ratios of indomethacin and sodium alginate (1:1, 1:2, 1:3, 1:4, 2:1, 2:3 & 4:1). Eudragit S-100 coating of indomethacin and sodium alginate microspheres are performed by coacervation phase separation technique. The microspheres were characterized by shape, particle size, size distribution. Entrapment efficiency, invitro drug release and stability studies. The outer surface of core and coated microspheres , which was spherical in shape, were rough and smooth respectively. The size of the core microspheres ranged from 20 -50 µm and the size of the coated microspheres ranged from 107 – 124 µm. The core microspheres sustained the release for 10 hrs in a pH progression medium mimicking the condition of GIT. The release studies of coated microspheres were performed in a similar dissolution medium as mentioned above. In acidic medium the release rate was much slower, however the drug was released quickly at pH 7.4 and their release was sustained upto 24 hrs. It is concluded from the present investigation that Eudragit coated sodium alginate microspheres are promising controlled release carriers for colon targeted delivery of indomethacin.

Keywords: Indomethacin, colon-specific, microspheres, sodium alginate, Eudragit S-100 & multiparticulate system.

ABSTRACT

The objective of the current study was to design and optimize Etodolac loaded Eudragit RS 100 microcapsules using solvent evaporation method. Quality by design approach was implemented for development of Etodolac microcapsules using I-Optimal RSM design. Based on initial risk assessment and preliminary study, two independent variables, Drug: Eudragit RS 100 ratio and stirring speed were selected for Design of Experimentation (DoE) to see effect on critical quality attributes (CQAs); entrapment efficiency and particle size. The prepared Etodolac loaded Eudragit RS 100 microcapsules were characterized for particle size, entrapment efficiency, in-vitro dissolution study, DSC, XRD and SEM. Acceptance criteria for CQAs were considered as particle size in the range of 22-200 µm and entrapment efficiency in the range of 72.86-97.25 %, which generated the design space with combination of selected critical parameters leading to the acceptable operating ranges for formulating microcapsules with respect to desired Target Quality Product Profile (TQPP). The obtained Etodolac loaded Eudragit RS 100 microcapsules were spherical in shape, having better entrapment efficiency and sustained drug release profile. Validation of model was carried out by comparing experimental values with predicted value of optimized formulation. Optimized formulations within design space were capable of sustaining drug release for about 22 hours and were expected to reduce dosing frequency thus reducing side effects associated with therapy.

Keywords: Etodolac, Eudragit RS 100, Quality by design, entrapment efficiency, particle size.

ABSTRACT

Shampoo is a hair care product used for the removal of oils, dirt, skin particles, dandruff, environmental pollutants and other contaminant particles that gradually build up in hair. It is a cosmetic preparation; its primary function is of cleansing the hair of accumulated sebum, scalp debris and residues of hair-grooming preparations. All shampoos are basically water and synthetic detergent mixtures. These shampoos of synthetic ingredients are harmful especially during regular usage. This causes severe dryness of hair and shaft leading fall in hair and destroying budding hair shafts. Herbal ingredients or their formulations are viable alternative to synthetic agents. The main objective of this study was to eliminate harmful materials from shampoo formulation and substitute them with a safe natural product.

Key words: Herbs, Hair Conditioning, Shampoo, Dandruff, Cosmetics

ABSTRACT

A rapid, specific reversed phase HPLC method has been developed for simultaneous determination of pantoprazole and levosulpridein their formulations. Chromatographic separation of these two pharmaceuticals was carried out on an Aligent,Zorbax column (250mmx4.6mm, particle size 5μm)with a 600:4000 (v/v/v) mixture of Potassium dihydrogen orthophosphate (pH-3.0; 0.01M)  buffer adjusted with Ortho phosphoric acid and methanol as mobile phase. The flow rate 1.0mL.min^-¹ and the analytes are monitored at 230nm.The assay results were linear from 240-720μg/mL for pantoprazole(r ² >= 0.9999) and 450-1350μg/mL for levosulpride (r ² >= 0.9999), showed intra- and inter-day precision less than 2.0%, and accuracy of 100%.The LOD was 0.00321 and 0.000549μg.mL^-¹ for pantoprazole and levosulpride respectively. Separation was complete in less than 5 min. Validation of the RP-HPLC method showed to be robust, precise, accurate and linear over the range of analysis.

Keywords: Pantoprazole and levosulpride, RP-HPLC, Validation.

ABSTRACT

The simple, sensitive, reliable and economically new method was developed for the estimation of Ramipril (RAM) and Telmisartan (TEL) by RP-HPLC in combined dosage form. After several trials with the different combinations and ratios of solvents, the present chromatographic parameters were optimized. It was found that potassium dihydrogenphosphate (pH 3.0): methanol: acetonitrile (30:20:50 v/v/v) was given satisfactory results. A C₁₈ column (Agilent ODS UG 5 column) having dimensions of 4.5mmx250mm was used. The mobile phase was pumped at a flow rate of 1.0ml/min and the eluents were monitored at 210nm. System suitability was carried out by injecting six replicate injections of 100% standard concentration, number of theoretical plates, HETP(height equivalent Theoretical plate) and resolution were satisfactory. The optimized chromatograms confirm the presence of Ramipril and Telmisartan at Rt: 4.1 min and Rt: 5.11min respectively without any interference. The concentration range of 1-5µg/ml for RAM and 8-40µg/ml for TEL were linear with correlation coefficients 0.999 and 0.989 respectively. The percent recovery studies were found to be 99.5-99.88% and 99.93-99.99% w/w for RAM and TEL respectively which indicate method was accurate. The proposed method was precise and reproducible with %RSD of 0.93 for Ramipril and 0.41 for Telmisartan, respectively. The limits of detection and limits of quantification were 0.10µg/ml and 0.25µg/ml for Ramipril 0.32µg/ml and 0.78µg/ml for Telmisartan, respectively. The method was found to be robust and ruggedness and was well suitable for the estimation of commercial formulations of selected combinations.

Keywords: Validation, RP-HPLC, Ramipril, Telmisartan, RSD and HETP.

ABSTRACT

Skin is being complex and the largest organ of the body, is vulnerable to wide range of diseases, like malignancy. It is most exposed part to harsh environment and its pollutants. Like increase in amount of Ultraviolet radiations involved in tumor induction and also co-carcinogen, ionizing radiation, nitrogen mustard, electron beam irradiation, chemical carcinogens, Viral infections acting as direct carcinogens or as promoting agents are predisposed to cutaneous malignancies. Diagnosis of skin tumors depends on correlating clinical clues and histological features. This study “occurrence of malignant tumors of skin in Karnataka” was carried out for 18 months, from 2005 to 2007. 54 skin tumors were studied. Out of these 40 were malignant tumors 74.07%.Skin tumors constitute a small but significant proportion of cancer patients. Unlike in the Western countries, SCC is the commonest histological variety. In India, the carcinogenic potential of both chemicals and radiation cannot be ignored.

Keywords: skin & adnexal malignancies, cancer of skin, cutaneous malignancy.

ABSTRACT

Drugs play a dual role in patients. They are intended to cure, prevent or diagnosesigns or symptoms of a disease and on the same side its improper use can cause drugrelated problems which lead to increased morbidity and mortality. A pharmacistin a hospital had a vital role to monitor the physician prescribed prescriptions fordrug related problems (DRP’s). Objectives: To identify the drug related problems like ADR’s, Drug Interactions(DI), Low dose (LD), High dose (HD), Treatment without indication (TWI)andUntreated indication (UI). To identify the patient demographic details. Materials and methods: ThePresent study is an observational prospective study done in a tertiary care hospital for a period of six months. Individual patient data withprescription content is collected every day in Medicinedepartment in a suitable data collection form. Ethical clearance is obtained fromthe ethical committee before the study commence. Results: In the total datacollection of 393 cases, 202 (51.3%) were males and 191 (48.6%) were females in which 388 DRP’s were found. In that 30 ADR’s, 239 DI, 27TWI, 47 UI, 20 HD, 25 LD are identified. Polypharmacy is also one of thereasons for drug related problems in the patients. Conclusion: Drug relatedproblems are one of the major problems seen in the hospital. The study suggests that the pharmacists and physicians need to work together to identify and resolve drug relatedproblems. Additional controlled studies are required to measure the effect of thisservice on health outcomes.

Keywords: ADR’s, Drug Interactions (DI), Treatment without Indication (TWI), Untreatedindication (UI), Low dose (LD), High dose (HD), DRP’s, pharmaceutical care services