IAJPR

Indo American Journal of Pharmaceutical Research

ISSN NO.: 2231-6876
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APRIL 2018
1

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR ESTIMATION OF ARGATROBAN IN BULK AND IN PHARMACEUTICAL DOSAGE FORM

Varsha Rajkumar Jamakhandi, Dr. M.S. Kalshetti, Prof. R.Y. Patil
Department of Quality Assurance, College of Pharmacy, Solapur, Maharashtra, India.

A simple, rapid and accurate method was developed for the estimation of Argatroban in bulk and in pharmaceutical dosage form and validated. Here, the solutions of Argatroban were prepared in methanol. The standard solution was scanned in the UV range (200-400 nm) in double beam UV spectrophotometer. It’s maximum absorption was found at wavelength 259 nm. Absorbance was measured at 259 nm and calibration curve was plotted as absorbance vs concentration. The method was found to be linear (obeys Beer’s law) in the range of 25-125 ?m/ml . The correlation coefficient was found to be 0.999 and regression of the curve was found as y=0.009x+0.052 with good recovery of 99.37-100.48%. The limit of detection and the limit of quantification were found to be 0.948 ?g/ml and 2.8755 ?g/ml respectively. The ruggedness and robustness were performed. All the parameters of analysis were chosen according to ICH guidelines and were validated statistically using RSD and % RSD with neat chromatograms.All the parameters were found to be satisfactory in accordance with the standard values. The proposed method can be used for routine practice for determination of Argatroban in bulk and in pharmaceutical formulations.

2

DEVELOPMENT AND VALIDATION OF Q-ABSORBANCE RATIO UV-SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND CANAGLIFLOZIN IN BULK AND COMBINED DOSAGE FORM

Nidhi Kotecha1,2, Jayvadan Patel2,3
1University of Colorado, Anschutz medical Campus, Denver, USA – 80045.
2Gujarat Technological University, Ahmedabad, Gujarat, India.
3Nootan Pharmacy College, Visnagar, Gujarat, India.

A rapid, simple, accurate and precise UV spectrophotometric Q-absorption ratio method was developed and validated as per the ICH-Q2 guidelines for the simultaneous estimation of Metformin and Canagliflozin. The method involved Q-absorption ratio analysis using two wavelengths obtained by the overlay spectrum of the Metformin and Canagliflozin, with one being the maximum absorbance wavelength of Canagliflozin (220 nm, 2) and the other being the iso-absorptive point of both drugs (250 nm, 1). The method was validated as per ICH guidelines. Linearity and range were determined by analyzing six independent concentration levels of calibration curve in the range of 5-17.5 ?g/mL for Metformin and Canagliflozin respectively (n=3). The value of correlation coefficient was > 0.99 for each of Metformin and Canagliflozin at 220nm and 250 nm. Accuracy of the method was confirmed by recovery study from marketed formulation at three levels – 80,100 and 120% of standard addition; the accuracy ranged between 99.63 and 101.14%. Intra-day and inter-day precision of Metformin and Canagliflozin was determined for three concentrations 5, 10 and 17.5 ?g/mL at 220 nm, 240 nm and 250 nm; and % CV was <1.0%. The proposed UV spectrophotometric Q-absorption ratio method is rapid, simple, precise, reproducible and economical that can be successfully employed for the industrial analysis of the combination of Metformin and Canagliflozin.

3

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND CANAGLIFLOZIN IN PRESENCE OF THEIR DEGRADATION PRODUCTS

Nidhi Kotecha*1,2,3, Jayvadan Patel2,3
1University of Colorado, Anschutz medical campus, Denver, USA – 80045.
2Gujarat Technological University, Ahmedabad, Gujarat, India.
3Nootan Pharmacy College, Visnagar, Gujarat, India.

A reversed-phase high-performance liquid chromatographic method was developed and validated for the simultaneous estimation of Metformin and Canagliflozin in the presence of their degradation products. Analytes were separated on Hypersil C18, 250x4.6 mm, 5?m column using an isocratic elution mode having a mobile phase composition of 50 mM potassium dihydrogen phosphate buffer (pH 3.0): methanol (50:50 v/v). Analytes were detected at a wavelength of 225 nm. A 20?L fixed-loop injector was used for the injection of samples at a flow rate of 1.0 mL min?1. The optimized method was validated as per ICH Q2 guidelines. The retention times of Metformin and Canagliflozin were 3.47 min and 5.28 min respectively. The linearity was assessed by analysis of a combined standard solution in the range of 5-20 ?g/ml for each of Metformin and Canagliflozin respectively. The correlation coefficient for calibration curves of Metformin and Canagliflozin were 0.999 and 0.999 respectively. Accuracy was calculated in terms of percentage recovery and was within the limits of 98-102%. Inter and Intra-day precisions were calculated as percentage relative standard deviation and were less than two percent. Limit of detection and limit of quantitation were within the limits of ICH-Q2 guidelines. Method was robust with % RSD values <2% with the deliberate changes in the composition of mobile phase, changes in the pH or change in the flow rate. Significant degradation was observed in the presence of acidic, basic, neutral, oxidative and photolytic stress conditions. The proposed RP-HPLC method is simple, precise, accurate, robust and reproducible and was successfully able to separate, identify and quantify the Metformin and Canagliflozin in the presence of their degradation products implies the stability indicating nature and specificity of the method.

4

FOURIER TRANSFORM-INFRARED SPECTROSCOPIC STUDIES ON EDIBLE Punica granatum FLOWERS

Suja Pandian. R*, Yuvaranjani .V
Department of Biochemistry, Rabiammal Ahamed Maideen College for Women, Tiruvarur, Tamil Nadu, India.

The present study has been designed to analyse Fourier transform?infrared (FT-IR) spectrum profile of the edible Punica granatum flowers. FT-IR spectrum was done to identify the functional groups of active components based on their peak values in the region of infrared radiation. The results of FT-IR analysis of the present study spectrum revealed the functional constituents such as alkanes, alkynes, amines, alcohol, alkenes, aldehyde and ketone, carboxylic acid, ketone were present in the crude powder of Punica granatum flowers. The results of our study generated the FT?IR spectrum profile of edible flowers of Punica granatum. The flowers provide opportunities to develop as medicines, value added products and dietary supplements which possess potential health benefits.

5

TO DEVELOP AND VALIDATE UV-SPECTROSCOPIC METHOD FOR THE ESTIMATION OF ?-LIPOIC ACID AND L-GLUTATHIONE REDUCED USING METHYLENE BLUE AS A DERIVATIZING AGENT

Pooja. D Dhruv*, Parula. B Patel*
S. J. Thakkar Pharmacy College, Opp. Seasons Hotel, Near N.R.I. Bunglows, Avadh Road, Kalawad Road, Rajkot-360005, Gujarat, India.

There are numerous drugs in the market that doesn’t have chromophore due to which it is very difficult to estimate. And if possible, the method is either tedious or costly. Hence a new novel approach for the estimation of drugs can be developed for their estimation using methylene blue as a derivatizing agent. The reaction mechanism undergoes the formation of leucomethylene blue from methylene blue which is a colourless substance, which further reacts with the target drug and forms a coloured compound that can be estimated using UV-Visible Spectrophotometer in the visible region (400-800 nm). The resulting outcome is the estimation of non chromophoric drugs in the visible region which was not possible till date using methylene blue as a derivatizing agent. The conclusion of using this is method is - very cost effective and an easy method for estimation of drugs in the visible region which is not possible without it’s derivatization. ?-lipoic acid and L-Glutathione reduced were estimated at 663 nm with the linearity range of 20-100 ?g/ml for ?-lipoic acid and 200-600 ?g/ml for L-Glutathione reduced.

6

PROTECTIVE EFFECT OF AERVA LANATA LINN., FLOWER EXTRACT AGAINST IMMOBILISATION STRESS INDUCED GASTRIC ULCERS IN RATS

Mr. Balakrishna Vuyyala*, Dr. Takkalapally Lakshmi
Department of Pharmacology, GNITC-School of Pharmacy, Ibrahimpatnam, Hyderabad.

The purpose of this study was to assess the effect of ethanolic extract of Aerva lanata linn., flower in experimentally immobilization stress induced Gastric ulcers in rats. Rats were divided into six different groups each having six. Group 1 served as a control, Group 2 received immobilisation stress (daily 1hr), Group 3, 4 and 5 served as extract treatment groups and received 50, 100, & 200 mg/kg orally, ethanolic extract of Aerva lanata flower and Group 6 served as standard group was received Ranitidine (20 mg/kg) orally. All the treatment protocols followed 15 days and after which rats were sacrificed, blood and stomach were taken for biochemical and Ulceration studies, respectively. The immobilisation stress treated group rats (G2) showed variable increase in serum Total protein, Total cholesterol, Triglyceride’s, Glucose, ALT, and ALP levels. Administration of ethanolic extracts of Aerva lanata linn., flower significantly prevented immobilisation stress induced elevation in the levels of serum diagnostic enzymes alanine amino transferase (ALT) and alkaline phosphatase (ALP), levels in experimental groups of rats. Moreover, total protein levels were significantly increased in treatment groups. The effect of extract was compared with a standard drug (Ranitidine). The changes in biochemical parameters were supported by histological profile. It is concluded that the ethanolic extract of Aerva lanata flower protects against immobilisation stress induced gastric ulcers in rats. In the present study treatment with Aerva lanata flower extract significantly decreased the elevated levels of Glucose, ALT, ALP, Triglyserides, glucose and increased the levels of Total proteins. From the results indicated that the ulcer protective activity of Aerva lanata flower may be due to the presence of several biochemical compounds. It is thus apparent that Aerva lanata possesses an ulcer protective activity.

7

A REVIEW OF ADULTERATION IN HERBAL MEDICINE WITH DIFFERENT CLASS ALLOPATHIC DRUGS

Ajay I Patel1*, NP Jivani2
1B.K. Mody Government Pharmacy College, Rajkot, Gujrat, India.
2Smt, R.B. Patel Mahila Pharmacy College, Atkot, Rajkot, Gujrat, India.

Herbal Formulations are highly popular worldwide because of the less side effect of the herbal formulation. Based on current research show that undeclared synthetic chemical constituents were found in the Therapeutic herbal medicines. Hence the quality of the herbal medicine are more concern by the world consumers and regulators. Intentionally or non-Intentionally some of the herbal medicine were contaminated by the microbial contamination, excessive or banned pesticide, heavy metal and chemical toxin with all possible problem. Adulteration of Herbal Medicinal Products with synthetic drug are producing major health risk and major concern to the drug regulatory agency. Some of the herbal supplements are adulterated with some unlabeled chemical constituents. Due to this take precaution against adulterated herbal medicines are necessary. In this review shown that there was many herbal medicines adulterated with chemical constituents and that was identified by different analytical techniques.

8

FORMULATION DEVELOPMENT AND EVALUATION OF CHEWABLE TABLET OF BENZOCAIN BY DIFFERENT BINDER CONCENTRATION

Mr. Sonawane M.P.1, Miss Gangurde R. R.1, Miss Bagul P.K.1, Mrs. Sonawane B. M.2
1Department of Pharmaceutics, Loknete Dr. J. D. Pawar College of Pharmacy. Manur, Kalwan.
2Department of Pharmacognosy, Loknete Dr. J. D. Pawar College of Pharmacy. Manur, Kalwan.

Benzocain is chemically described as ethyl ester of para amino benzoic acid having local anaesthetic activity.It is readily absorbed from mucous membrane and poorly absorption through the skin .In water and dilute acid it is sparingly soluble and in chloroform and ethanol it is very soluble. Generally its administration by oral route.In case of throat disorders the patients who cannot swallow tablets hence benzocain chewable tablets helps to improve patient compliance. Chewable tablets were prepared with PVP k30 binder with different concentration 20 %, 30% and 40 % Tablet prepared by wet granulation method were performed and evaluation is done for different parameters such as weight variation, Hardness, percent comprasability , Tapped density, friability , Content uniformity ,Disintegration etc. All parameters were found within specifications of 30 % binder concentration . Assay value limit were found with in limit 95% to 110%.

9

AN ATTITUDE & KNOWLEDGE OF PHARMACISTS TOWARDS PHARMACOVIGILANCE & ADR REPORTING AND BARRIERS - A CURRENT SCENARIO IN TAMILNADU

D. Krishnarajan*, Mathiyazhagan G, Tamilselvan A, A. Srinivasan, Sivasakthi K, B. Shiva Ranjini, S. Kalaivani
JKKMMRFs AJKK SA College of Pharmacy, Komarapalayam, Namakkal - 638183, Tamilnadu, India.
The Tamilnadu Dr.MGR Medical University, Chennai, Tamilnadu.

Background: An adverse drug reaction (ADR) is associate degree injury caused by taking a medicine. The Study entitled “An Attitude & Knowledge of pharmacists towards pharmacovigilance & Adr reporting and barriers in current scenario; in Tamilnadu” was designed to assess the awareness of Pharmacovigilance and ADR reporting. Methods: This was a prospective cross sectional study involving registered community pharmacists and hospital pharmacists to evaluate the knowledge, perception and practice of pharmacovigilance which was conducted by face to face questionnaire over a period of 6 month duration included a total 274 (78%) participants out of 350. Results: Out of the total participants 222(81.02%) had fair knowledge about ADR, 79(28.83%) had fair knowledge, about pharmacovigilance. 68 (25.09%) of participants were aware of National Pharmacovigilance Programme in India, 41 (14.96%) of participants knew how to report an ADR and 112(40.87%) of participants knew when and what to be report as ADR. 245(84.41%) of pharmacists believed that the ADR reporting should be mandatory for pharmacists. Among the participants 78(28.46%) of pharmacists only had facility for ADR reporting. 212(77.37%) of participants unaware of excistence of national adr reporting system. Conclusion: This survey on pharmacovigilance and ADR reporting among pharmacists in Tamilnadu suggests that the pharmacist may lack in-depth understanding of the facts about ADR reporting and may need more information on the National Pharmacovigilance System and ADR reporting process. Since there is a need of educational programs about ADR reporting and pharmacovigilance in the pharmacy. 


 


10

PREDNISOLONE INDUCED CUSHING’S SYNDROME IN SEROPOSITIVE INFLAMMATORY ARTHRITIS: A CASE REPORT

Sharad Chand*, Ramesh Bhandari, Varun Lal
Department of Pharmacy Practice, TVM College of Pharmacy, Ballari, Karnataka-583103.


Aim-The main aim of the study is to report the drug related problem occurred in order to prevent its recurrence Case presentation-A 23 year female patient presented with complaint of generalized swelling of body since 8 days, breathlessness since 3 days and fever since 3 days. She is Known case of seropositive inflammatory arthritis since 1 year and taking prednisolone 20 mg b.i.d. Examination-She was having tachycardia, oedema, moon shape face. Lab investigation-her serum cortisol level is elevated and anti CCP antibodies were present hence diagnosed as prednisolone induced cushingoid syndrome with seropositive inflammatory arthritis. Treatment-She was treated with Inj. Furosemide 4o mg IV b.i.d., Neb. Budesonide + Salbutamol every 6 hourly, Tab. Hydroxychloroquine 200 mg PO b.i.d., Tab. Methotrexate 15 mg PO Once a week, Tab. Calcium carbonate 500 mg PO o.d. and other symptomatic treatment. Conclusion-The prednisolone was withdrawn in tapered manner and the patient became normal and discharged. 


 


11

“STUDY OF DRUG-DRUG INTERACTIONS IN INPATIENTS ADMITTED TO DEPARTMENT OF GENERAL MEDICINE AT A TERTIARY CARE TEACHING HOSPITAL, BALLARI KARNATAKA”

Dr. RoopaShree P.M*, Dhruba Rana Chhetri, Varun Lal, Sujit Kumar Sah, Sahithi Reddy D, Kotha Ashok Guptha
Department of Pharmacy Practice, TVM College of Pharmacy, Ballari, Karnataka.

Background: Drug can be useful tools in the prevention and treatment of symptoms and diseases, but if not use properly, they may be harmful and cause new symptoms. Clinically significant drug interactions can occur when two or more drugs are taken in combination. Objectives: To study potential Drug -Drug interactions in inpatients medication charts in general medicine department of a tertiary care teaching hospital in Ballari. Methodology: The study period was 6 months. Data of all the subjects prescribed with more than two drugs. Results and Discussion: A total of 220 prescriptions were analyzed of which 150(68.18%) cases were identified with DDIs and 70(31.82%) were without DDIs .Among 150 patients 124(56.36%) were males and 96(43.64%) were females. In correlation higher prevalence rate of DDI among males (62.70%).Out of 150 cases a majority of DDI were found frequently in the age group of 59-68(20.667%). A total of 676 DDIs were obtained from 150 cases. From these 97(14.35%) were of Major severity, 434(64.20%) were of moderate severity and 145(21.45%) of minor severity. Drugs with potential DDIs identified, followed by anti-platelets (n=154), Anti-diabetic (n=110). Among 150 cases Pharmacokinetic outcome was identified in 172 DDIs, Pharmaco-dynamics outcome was indentified in 435 DDIs and 69 were Non specified interactions. Among 150 patients there were 55(25%) with Cardiovascular diseases,53(24.09%) with Renal disorders,32(14.55%) with Respiratory disorder, 22(10%) with Central nerves system disorder, 21(9.55%) with Endocrinal disorder, 16(7.27%) with GI, 10(4.59%)with Blood disorder, 7(3.18%) with Hepatic disorder, 20(0.9%) with Immune system disorders and 2(0.9%) were Others. 


 


12

NEUROBLASTOMA AND ITS THERAPY - A REVIEW

Sk. Seshma Ifthulla*, P. Hari Priya*, Dr. G. Susmitha, Dr. G. Ramesh, Dr. V. Tejaswi, Satheesh. S. G, Dr. P. Srinivasa Babu
Department of Pharmacy Practice, Vignan Pharmacy College, Guntur.

Neuroblastoma (NBL) is a malignancy of the sympathetic nervous system seen in children, infants, foetus, and embryos. The organs likely to affect include Adrenal glands, above the kidneys or nervous tissue adjacent to spine, neck, chest and pelvis. Skin, Bone, Lymph nodes, Bone marrow are effected by metastasis. The most common symptoms seen are a lump in the abdomen, chest or neck, Bulging eyes, Dark circles around the eyes, Bone pain, Swollen stomach & troubled breathing in babies, Painless, bluish lumps under the skin in babies and inability to move a body part. Inability to empty the bladder, Loss of movement of the hips, legs, or feet, uncontrolled eye movements or leg and feet movements. Disease can be diagnosed by Complete Blood Count, Biopsy, and Genetic studies, CT- Scan, PET CT-Scan and MRI. Treatment can be done by surgery, radiation therapy, chemotherapy, biologic therapy, or a combination. Anti-GD2 monoclonal antibody (mAb) in combination with systemic cytokine immunotherapy shows clinical efficacy in high-risk NBL patients. Targeted therapy using Histone Deacetylase Inhibitors (HDACi) is currently being explored in cancer treatment.

13

A Comparative Study of Metformin plus Sulfonylureas Versus Metforminalone for Its efficacy In Type 2 Diabetes patients In South Indian Tertiary Care Teaching Hospital

Narasimha Rao.B1, Lokesh .A1, Lahoor Basha. S1*, Prashanth.M1, Vijaya Narasimha Reddy.P2.
1P.Ramireddy Memorial College of Pharmacy, Cuddapah, Andhra Pradesh-506003, INDIA.
2Rajiv Gandhi Institute of Medical Sciences, Cuddapah, Andhra Pradesh-506003, INDIA.

The objective of the study was to compare the efficacy of combination containing Metformin plus Sulfonylureas (MET+GLI/GLIB) and to determine whether combination of Sulfonylureas had clinically remarkable benefit over Metformin alone (MET) in patients with Type 2 Diabetes. This was a single centric, open labelled, prospective study, involving 70 Type 2 diabetes patients betweenage group of 18-75 yearsold. Data of only Type 2 diabetic patients who were prescribed either Metformin 500 mg,Metformin plus Glimepiride (500+2) mg and Metformin plus Glibenclamide (500+5) mg were included in the study. Efficacy was evaluated based on changes in RBS and FBS at every follow-up of one month for totally 3 months. Total of 70 patients were enrolled in the study but 6 patients lost follow up in MET Group and 2 patients in MET + GLI Group. Therefore 24 patients in MET, 18 patients in MET + GLI group and 20 patients in MET + GLI group completed study. A statistically significant reduction in RBS and FBS was seen in all the groups. MET + GLI treatment showed a statistically significant reduction in RBS at third month as compared to other groups.Study demonstrated that combination of Metformin+Glimepiridetreatment was more effective than Metformin+Glibenclamide and Metformin alone in reducing Fasting blood sugar and Random blood sugar. Thus Combination therapy of Metformin with Glimepiride seems to be a better treatment in patients having Type 2 diabetes.

14

NEW APPROACHES FOR SOLUBILITY ENHANCEMENT OF POORLY WATER SOLUBLE DRUG: - AN OVERVIEW

Shruti Jaswal, Rajeev Garg*
Department of Pharmaceutics, A.S.B.S.J.S.M. College of Pharmacy, Bela, 140111(Punjab), India.

A success of formulation depends on how efficiently it makes the drug available at the site of action. The solubility is the one of the most challenging aspects in formulation and development of dosage forms 40% of the new chemical entities currently being are poorly water soluble drug or lipophilic. Poorly water soluble drugs after oral administration often require high doses to reach therapeutic plasma concentration. Solubility is the phenomenon of dissolution of solid in liquid phase to give a homogenous system. There are various techniques which are used to improve or enhance the solubility of poorly soluble drugs, which include physical and chemical modification and other methods like salt formation, particle size reduction, solvent evaporation solid dispersion and so forth. Solid dispersion is the one of the techniques adopted for formulation of such drugs.

15

ANTIHYPERGLYCEMIC ACTIVITY OF HOLOSTEMMA ANNULARIS K. SCHUM ROOT EXTRACTS IN STREPTOZOTOCIN-INDUCED DIABETIC WISTAR RATS

Srinivasa Rao Avanapu1, Sudharshan Reddy Dachani*2
1Bhaskar Pharmacy College, Department of Pharmacology, Yenkapally (Vi) Moinabad (Mo), Hyderabad.
2Nizam Institute of Pharmacy, Deshmuki (Vi), Pochampally (Mo), Nalagonda (Di) 508284, Andhra Pradesh, India. Hyderabad.

As incidence of diabetes is increasing worldwide, besides it is associated with complications, this study aimed to evaluate the Anti-hyperglycemic activity of the roots of Holostemma annularis K. Schum (Asclepiadacae) in Streptozotocin (STZ) induced diabetic Wistar rats. Diabetes as induced in rats by an intraperitoneal injection of streptozotocin (50 mg/kg). Extract was orally administered to diabetic rats for a period of 16 days. Animals were divided into seven groups (n=6) receiving different treatments: Group I: Normal (Control), Group II: Diabetic (control), Group III: Standard drug glibenclamide (5 mg/kg, orally). Group IV and Group V: Chloroform Extract of Holostemma annularis (CEHA 150 and 300 mg/kg) and Group VI and Group VII Alcoholic Extract of Holostemma annularis (AEHA) (150 and 300 mg/kg). Blood serum was analyzed for the following biochemical parameters like serum glucose, serum insulin, Urine creatinine, total proteins in urine and histopathological study of pancreas was examined. Significant results were observed in the estimated parameters. It is concluded that, the anti-hyperglycemic effect of Chloroform and Alcoholic extracts of Holostemma annularis may be due to both reductions in glucose level and improvement in histopathological studies. Hence, it is proved that Holostemma annularis is having anti diabetic activity in streptozotocin induced diabetic rats.

16

LIPID LOWERING ACTIVITY OF A POLYHERBAL FORMULATION ON TRITON WR-1339 (TYLOXAPOL) INDUCED HYPERLIPIDEMIA IN WISTAR RATS

Sudharshan Reddy Dachani, Kenneth Nelson
Department of Pharmacy Practice, College of Pharmacy-Boys, Shaqra University, Al-Dawadmi, K.S.A-1678.

We investigated the possible antihyperlipidemic activity of a hydroalchoholic extract of an herbal preparation from a combination of three Indian medicinal plants against Triton WR-1339 induced hyperlipidemia in male Wistar rats. The current study was undertaken to assess the hypolipidemic, hypocholestrolemic and hypotriglyceridemic potential of the Polyherbal Formulation (PHF) using Triton WR-1339 (Tyloxapol) induced hyperlipidemia. The male Wistar rats were divided into five groups’ of six animals in each group normal control, hyperlipidemic control, hyperlipidemic plus polyherbal extract and hyperlipidemic plus Atorvastatin. Hyperlipidemia was induced in overnight fasted Wistar rats by single intravenous (IV) injection of 200 mg/kg or 2ml/kg of Triton WR-1339 in Normal Saline (0.9% NaCl) and it showed sustained elevated levels of serum Total Cholesterol (TC), Triglyceride (TG), LDL-C and VLDL. The Polyherbal Formulation (200 and 400 mg/kg/b.w. /p.o.) and Atorvastatin (10 mg/kg/b.w. /p.o.) was administered orally for seven days to Triton Wr-1339 induced hyperlipidemic rats. The PHF significantly decreased serum total cholesterol, triglyceride, LDL-C, VLDL, Atherogenic Index and increased HDL-C levels. Atherogenic Index and Triglyceride and cholesterol secretion rate were lowered in the polyherbal extract fed animals when compared to hyperlipidemic control animals. Polyherbal extract exhibited quite competitive potential when compared with the reference drug Atorvastatin affording a possible alternative natural therapeutic agent in the treatment of hyperlipidemia. The present work provides scientific evidence of therapeutic potential of hydroalchoholic extract of polyherbal formulation against hyperlipidemia. Hence, we suggest that the inclusion of this PHF in the management of hypercholesterolemia and hypertriglyceridemia.

17

RECENT ADVANCES IN PILOT PLANT SCALE UP TECHNIQUES - A Review

AvinashV.Dhobale*1, Arun M.Mahale2, Mrunal Shirsat3, Shriram Pethkar4, Vijay Chakote5
1LCOP Hasegaon.
2SNIOP,Pusad.
3Dr. N. JPaulbudhe College of Pharmacy Ahamadnagar.
4Latur College of Pharmacy (B.Pharm), Hasegaon.
5Atsvp College of Pharmacy Hatta.

Pilot scale up techniques for solid dosage form will provide guide line forthe manufacture of large scale process and this will play a pivotal role inlarge scale manufacturing. The parameters such as granulation feed rate,compression parameters, temperature and rate of drying will have acritical role in development of any solid dosage form.Pilot plant is a relative term in the sense that pilot plants are typically smaller than full-scale production plants, but are built in a range of sizes. Also, as pilot plants are intended for learning, they typically are more flexible, possibly at the expense of economy. Some pilot plants are built in laboratories using stock lab equipment, The past two decades particular have witnessed amazing inventions and innovations in pharmaceutical research, resulting in the ability to produce new drugs faster than even before. The new drug applications (NDAs) and abbreviated new drug applications (ANDA) are all-time high. The preparation of several clinical batches in the pilot plant provides its personnel with the opportunity to perfect and validate the process.

18

A REVIEW ON TOPICAL LIPOSOMES: A NOVEL DRUG DELIVERY SYSTEM

Lalita Devi*, Punam Gaba, Dr. Sandeep Kumar
Department of Pharmaceutics, ASBASJSM College of Pharmacy, Bela (Ropar).

This review will highlight work done in our laboratories formulating and evaluating topical liposomal delivery is a mostly used both in vivo and in vitro methods by using animal models .The recent therapeutic work done on drug delivery using Topical Liposomes as carrier for small and large molecules. Topical Liposomes are solid colloidal particles in size from 10nm-1000nm. They are sphere shaped vesicles made up of one or more phospholipid bilayers. It shows greater affinity towards horny layer of skin and penetrates skin deeper tissues with more absorption rate. When topical liposomes are applied on the skin, they act as a solubilizing matrix for poorly soluble drugs and reduce the side effects of these drugs. Topical liposome formulations are more effective and less toxic than conventional formulations (Tablets, capsules etc.). They also alter and improve pharmacokinetic and pharmacodynamic properties of less efficacious drugs. This review discusses the potential advantages in topical drug delivery, mechanism of action, method of preparation, characterization and application of Topical Liposomes drug delivery system.

19

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF LETROZOLE IN PURE AND PHARMACEUTICAL DOSAGE FORM

Siddharth M. Patil*, Sunil T.Galatage, Avinash U.Choudhary
Department of Pharmaceutics, KLE’S College of Pharmacy, Nippani, Karnataka, India.

In this present research work we developed a validated UV spectrometric method for Letrozole. It is simple, fast, accurate, cost efficient and reproducible spectrophotometric method, developed for the estimation of Letrozole in pure and pharmaceutical dosage form. Based on measurement of of absorption of UV light, the spectra of Letrozole in acetonitrile as a solvent showed maximum absorption wavelength (max) at 240 nm. The calibration curve was plotted over the concentration range from 1-24 ?g/ml of Letrozole with correlation coefficient 0.999. Validation was performed as per ICH Q2 guidelines for linearity, accuracy, precision, and recovery. This method has good reproducibility with % RSD less than one. The limit of detection (LOD) and limit of quantification were found to be 0.0470and 0.1424 respectively by simple UV spectroscopy. Thus proposed method can successfully applied for Letrozole in routine analysis work.