Department of Pharmacy 2012 - Sumandeep …...Formulation & development of Bilayer tablet of...

Department of Pharmacy 2012

1 Compendium of Research

Message of Principal

I am pleased to present first annual research compendium of Department of Pharmacy

which a compilation of research and development activities conducted in a calendar year.

This compendium comprises of detailed information of the publication, ongoing and

completed research projects by the students and the faculties.

Department of Pharmacy is an institute devoted to conducting, supporting, and

encouraging research. It has a well established research facility to achieve the goals of the

department in the field of research. In order to give impetus to the research activities we

have well qualified faculties and the good resource centre at our central library. This is the

first research annual compendium which reflects our strength and hard work showing

inclination of the students and the faculty towards the research in various fields of

pharmacy. No doubt, there were many challenges came in fulfilling this goal but the

enthusiasm of our dedicated faculties overcome all hurdles to achieve their

accomplishment. I assure that this commitment of the faculties of the department will be

continued in the time to come. I would like to compliment all the researchers and the

researcher scholars who have contributed their knowledge and the novel research ideas at

the department. I also congratulate the compilation team to bring this compendium as the

ready reference of our dedication towards research and development.

Dr. A K Seth

Principal / HOD,

Department of Pharmacy,

Sumandeep Vidyapeeth,

Piparia, Vadodara



Contents

Sr. no Title Page no. 1 Research Policy 2 Ongoing research projects 3 Completed research projects 4 Published papers



Research Policy

Introduction

This policy establishes the research environment within which academic staff and postgraduate

research students carry out their research. It also provides an overarching framework for the

development and implementation of all research management at Sumandeep Vidyapeeth

Objectives

To develop a proactive mechanism for smooth implementation of research projects.

To promote research culture among the staffs and students of the university.

Simplification of procedures like sanctions/purchases for research projects and other aspect.

To motivate researchers to apply for external funding agency.

To promote the publication from all research projects.

Practices

Central research committee circulates the notification regarding inviting research projects

from the students and staff of each constituent unit of university twice in a year.

Interested candidates write a research proposal in the prescribed format provided by central

research committee and submit it to central research committee in given time limit.

Research scholar can also apply for the research fellowship/ financial assistance / grant to

university / External agency as per procedure guideline given by central research committee.

Central research committee reviews the research projects thoroughly scrutinizes the

submitted projects, identifies the need of research projects & thrust areas of research project

submitted by research student/faculty/scholar of the respective department.

The research projects which fulfill the entire criterion and satisfy the research thrust

possessing will be considered for funding.

The Central research committee will call external experts for reviewing of projects.

The principal investigator has to obtain the SVIEC permission before commencement of the

research work.

The Principal investigator should commence his/her project at the pre-decided date and

complete in a stipulated time period.

The Principal investigator must follow the SV instrument purchase procedure for any

procurement of instrument/equipment.



Minimum one fourth grant will be disbursed at the initial stage and subsequently further

installments will be disbursed on submission of utilization certificate along with bills and

account statement of the previous grant.

The First installment will be disbursed with a written application for grant with SVIEC letter

to Director Research Cell.

All communication related to grant utilization or withdrawal of installments shall route

through Director, Research Cell.

Any patent generated by research work under this scheme will be shared with Sumandeep

Vidyapeeth.

In all publications, it is mandatory to include the name of Sumandeep Vidyapeeth.



Ongoing research projects

Industry sponsored research projects

Sr. No. Name of the project Industry name Funds

received (Rs)

1 Effect of Normacid syrup and

powder in experimentally

induced peptic ulcer in mice

Ayur Lab, Halol 18,000/-

2 Effect of Dibolin PHF in

experimentally induced type

2 diabetes in rats


3 In vivo evaluation of AHR – 1

(PHF) on anaphylaxis model

in rats




PG Students research projects

Sr no Name of student Title of the project

1. Juned M gazi Formulation evaluation and opatimisation of beta cyclodextrine inclusion complex of aceclofenac

2. Mahesh C Rathi Development and characterization of nanoparticulate delivery system of quetiapine

3. Vishal N Raval Formulation evaluation of gastroretentive drug delivery of gliclazide

4. Anju Kanojiya Formulation, Evaluation and opatimization of self emulsifying grug delivery system an antifungal drug

5. Jayesh J Patel Design, development,Optimization and characterization of aceclofenac loaded ethosome for transdermal delivery

6. Aniket R Raval Formulation, Evaluation and opatimization of Mebendazole colon targeted sr pellets by extrusion spheronization

7. Milan S Patel Formulation evaluation and opatimization of dry suspension formulation of azithromycin

8. Hemil H Desai Formulation and evaluation of enteric coater pellets of esomeprazole compressed into delayed release tablets

9. Pratik Patel Formulation, developamet and evaluation of chlorhexidine gluconate gel for periodontitis

10. ketan D Patel Formulation and evaluation of atorvastatin nanosuspension for bioavailability improvement

11. Sonu D naik Process validation of loperamide HCI tablet

12. Hardik Shah Validation of water treatment system and heating ventilation and air conditioning system in Pharmaceutical industry

13. Dhaval N Darji Development and validation of stability indicting method for the assay and related substance of acipimox in bilk drug form by HPLC

14. Krishna R Patel Development and validation of RP- HPLC method for estimation

15. Ishwardan J. gadhvi HPLC Method development and validation for estimation of withaferin a in poly -herbal formulation

16. Kinnar P patel Development and validation of stability-indicating method for the assay and related substance of ceftriaxone in ceftriaxone for injection USP

17. Ankit Prajapati Analytical method development and validation of voglibose and metformin in combined dosage form

18. Krupa D Shah development and validation of paracetamol and tramadol in tablet dosage form by UV method and HPLC method

19. Prdip G Parikh Retrospective process validation of roseamine soft getatin capsule



20. Maunang M Patel Analytical method development and validation of lawsone in polyherbal formulation by HPC

21. Vimaldas Patel Enhancement of dissolution profile o f lornoxicam tablets by improving its solubility by various techniques

22. Imran Umatiya Formulation and evaluation of solid lipid nanoparticles of isoniazid

23. Mr Ankit Patel Development and characterization of new natural polymer for the formulation of sustained release oral dosage form

24. Juhi D Patel Design,development and characterization of ph sensitive hydrogel for intestinal delivery of prednisolone

25. Hiren Patel Formulation and evaluation of nanoemulasion of ketoconazole for topical delivery

26. Devendra Sharma Preparation and evaluation of aceclofenac topical microemulsion gel

27. Sunny Shah Design, development, opatimization and charaterization of immediate release tadalafil tablet

28. Chirag S Patel Preparation and in -vitro characterization of methotrexate loaded nano suspension

29. Jaymin N Desai New analytyical method development and validation od cefixime and linezolid in tablet dosage form

30. Chirag M Patel Analytical method development and validation of cefixime and azithromycin in combined dosage form

31. Viral Shah Development and validation of cetypyridinium chloride and benzocaine by Rp-HPLC method

32. Mukesh Rathi New analytical method development and validation of tramadol hydrochloride and dicyclomine hydrochloride in tablet dosage form

33. Sujit Kumar Sharma New analytical method development and validation of tolperison hydrochloride and diclofenac sodium in dosage form

34. Snehak K Tank New analytical Method development and validation of tolperisone hydrochloride and lornoxicam in tablet dosage form

35. Vivak Dhola Effect of tank wood seed alone and combinition with vitamine and lycopic acid on ethylene glycol and vitamin D3 induce urolithiasis in rat

36. Barvaliya Nitesh Effect of curcumin and several antioxidenta on doxorubicin induced cardiotoxicity in rat

37. Shivam S Jani In vivo evaluation of PHF on anaphylaxis model on rats and G. pig

38. Priydutt S Bhatt New analytyical method development and validation od cefixime and linezolid in tablet dosage form

39. Manoj R Patel Analytical method development and validation of cefixime and azithromycin in combined dosage form



40. Jaymin D Patel Formulation and characterization of nanosuspension of an anti- viral drug

41. Ghanshyam V Patel Design, Formulation and characrerization of cyclosporine loaded colon targeted microspheres for the treatment of rheumatoid arthritis

42. Manan Shah Design, development and Optimization of sustain release metoclopramide microsphere

43. Gandhi Kevin S Formulation and evaluation of carbamazepine extended release tablets

44. Ashwin Patel Losartan potassium loaded transdermal patch: Design and I vitro characterization

45. Sachin R Patel Formulation, opatimazation and evaluation of gastro retentive controlled release floating microspheres of venlafaxine HCL

46. Kashyap Patel Design evaluation of controlled release floating microspheres for better management hypertension



Faculty research projects

1. Dr. Rajesh Maheshwari

Effects of coenzyme Q10 with antidiabetic and antihyperlipidemic drugs in experimental induced diabetic complication.

2. Dr. Ujjwal Sahoo

Design synthesis and pharmacological evaluation of novel oxadiazole, triazole and thiazolidinone-4-one

3. Mr. Sachin Chauhan

Design development optimization and evaluation of nanoparticulate drug delivery system of some anticancer drug.

4. Mr. Nirmal Shah

Techniques to improve bioavailability of Selective Estrogen Receptor modulators (SERMs) for treatment of osteoporosis

5. Mr. Ashim Kumar Sen

Development and validation of new analytical methods of some group of pharmaceuticals from its bulk and pharmaceutical dosage form

6. Mrs. Dhanya Sen

Development and validation of new analytical methods of some antihypertensive and antidiabetic group of pharmaceuticals from its bulk and pharmaceutical dosage form

7. Mr. Girish Sailor

Design development optimization and evaluation of novel drug delivery system of some phytopharmaceuticals.

8. Mrs. Falguni B Tandel

Analytical method development and pharmacokinetic study of some new anti-inflammatory agents

9. Mr. Ankur Javia

Design, development and characterization of colon cancer targeting folic acid conjugated Capecitabine nanoparticles

10. Mr. Chintan Aundhia

Formulation design and development of nano carrier system for treatment of osteoporosis

11. Mr. Ghanshyam Parmar

Pharmacognostic and pharmacological standardization of some Euphorbias plants.

12. Mrs. Aarti Zanwar

Analytical method development and validation of some drugs combinations.



Completed research projects

PG Students research projects

Sr no Name of student Title of the project

1. Ronak Patel Formulation & evaluation of sublingual dosage forms of prazocin HCL

2. Kirtida Patel Formulation & evaluation of Ralonazine HCL microsphere

3. Jaymin Patel Formulation & evaluation of Methotrexate loaded nanoparticles

4. Chainesh Shah Formulation & evaluation Gastroretentive Floating microsphere of atorvastatin

5. Patel Lav Formulation & evaluation of Imidiate release tablet of Antihistaminic drug

6. Savaliya Jitendra Formulation & evalution of floating matrix tablet of atenolol.

7. Pathak Prashant Formulation & evalution characterization & invitro evaluation of aceclofenac solid dispersion in crporated gels

8. Bhagat Chintan Bioavailability improvement of Candensatron by various technique for treatment of Hypertension

9. Dhamat Khushal Dissolution enhancement of poorly soluble Aceclofenac by complexing with B- cyclodextrin

10. Bhalala Chirag Formulation & development of Bilayer tablet of Metformin HCL & Pioglitazone HCL

11. Shah Zeel Formulation & development of modifide solid oral dosage form for the treatment of cardiovascular disorder`

12. Vagada Rajnikant Formulation & evaluation of Novel gum based drug delivery system of Antiemetic

13. Pranay B. Patel

Development and validation of stability indicating method for the determination of assay and chromatographic purity of Cefepime for injection USP in bulk drug and pharmaceutical dosage form by RP - HPLC

14. Chauhan Urvashi Quantitative determination of Minocycline HCL & Zolpidem tartarate in pharmaceutical formulation

15. Patel Dhara Development & method validation of stability indicating RPHLC method for piperacillin tazobaclum PSU

16. Radadiya Rasik J. Analytical method development for estimation of Ranolazine & Eszopiclone in bulk & tablets

17. Vaghasiya Abhay Process validation of ciprofloxacin hydrochloride tablet

18. Parmar Purvi Process validation of artemether & lumefantrine tablet 80/ 480mg.

19. Sudani Tushar Development & validation of assay method for Silodosin by Rp-HPLC method in pure and marketed formulation



20. Joshi Maharshi New analytical method development and validation of Domperidone and Naproxen in pharmaceutical formulation

21. Joshi Harsh New analytical method development and validation of Rosuvastatin and Ezetimibe in tablet dosage form

22. Makvana Jigar R Development of anlytical method for estimation of EPL

23. Patel Anjal Effect of Rosuvastatin cabbage & normacid on experimental induced ulcer in mice



Amin N, Khandhar A, Seth A. Development and validation of stability

indicating assay method for lornoxicam& tramadol in tablet dosage form by

rp-hplc. Pharma Science Monitor. 2012;3(2).

Abstract

A simple, selective, precise and stability indicating high-performance liquid

chromatographic (HPLC) method for determination of Lornoxicam & Tramadol HCl in

tablet dosage form was developed & validated. The chromatographic conditions comprised

a reverse-phase C18 column (Inertsil ODS 3V C-18, 250 x 4.6 mm, 5 μ with a mobile phase

consisting of a mixture of solution (5.7606 gm Ammonium dihydrogen phosphate in 2000

mL of milli-Q water, 7.3 pH adjusted with Tri ethylamine) & Acetonitrile in the ratio of

70:30, %v/v. The flow rate was kept 1.5 ml/min. and the detection was carried out at 230

nm. The retention times of Lornoxicam & Tramadol were 12.2 & 6.5 min. respectively. The

linear regression analysis data for calibration plots showed good linear relationship with

coefficient of correlation values, r = 0.999 for Lornoxicam& Tramadol HCl in the

concentration ranges of 0.16- 96 μg mL-1 & 0.2- 400 μg mL-1 respectively. LOD values

were found to be 0.16 & 0.2 μg/ml for Lorno&Trama respectively. LOQ values were found

to be 0.53 & 0.67 μg/ml for Lorno & Trama respectively. The method as validated for

precision, recovery, and robustness. The lornoxicam & tramadol HCl undergoes

degradation under acidic, basic, oxidative, photochemical, and thermal conditions.

Statistical analysis proves that the method is reproducible & selective for the estimation of

Lornoxicam& Tramadol HCl under study. As the method could effectively estimate the

vitamins in the presence of their degradation products, it can be employed as a stability

indicating method.

Keywords: Lornoxicam, Tramadol HCl, Validation, Stability indicating method



Chirag P, Ujwal S, Seth A, Viral S, Umesh U. Formulation and evaluation of

solid dispersion of olanzepine. Pharma Science Monitor. 2012;3(3).

Abstract

The poor dissolution rate of water-insoluble drugs is still a major problem conforming the

pharmaceutical industry. Therefore, the enhancement of the dissolution rate of poorly

water-soluble drugs after oral administration is one of the most challenging aspects of

modern pharmaceutics. Olanzepine exhibits very slight solubility in water and as a

consequence it exhibit low bioavailability after oral administration. Therefore, the

improvement of olanzepine dissolution from its oral solid dosage forms is an important

issue for enhancing its bioavailability and therapeutic efficacy. The purpose of present

work is to improve the solubility of Olanzepine by preparing its dispersion with polymer

PEG(Poly Ethylene Glycol) using solvent evaporation technique.

Keywords: Olanzepine, Solvent Evaporation, Solid Dispersion, Solubility



Desai D, Seth A, Molvi K, Mansuri M, Prajapati B. Synthesis and

antibacterial activity of nickel complex of some novel nitroimidazole. Pharma

Science Monitor. 2012;3(2).

Abstract

The Ni(II) complex of novel, 2-(1-(substituted)-5-nitro-1H-imidazol-2-yl)-1-(substituted)

ethanone have been synthesized and characterized by FTIR, molar conductivity, 1 HNMR,

MASS. Novel 2-nitroimidazole act as a bidentate ligand through the 3-N of imidazole ring

and C=O, at 2-position of nitroimidazole, which coordinate the metal ion give rise to 4-

coordinate tetrahedral Ni(II) complex. The in vitro antimicrobial activity was determined

by using cylinder plate method. The compounds were found to be more active than ligand

against Gram-positive bacteria, B. Pumilus ATCC 14884, S. aureus ATCC 29737 and Gram

negative bacteria, S. aboney NCTC 6017.

Keywords: nitroimidazole, complex, Nickel chloride, ligands.



Desai J, Khatri N, Chauhan S, Seth A. Design, development and optimization

of self-microemulsifying drug delivery system of an anti-obesity drug. Journal

of pharmacy &bioallied sciences. 2012;4(Suppl 1):S21.

Abstract

The aim of the present work was to formulate a self-microemulsifying drug delivery system

(SMEDDS) containing orlistat. The oil, surfactant, and co-surfactant were decided based on

the solubility studies. Pseudoternary phase diagrams were plotted, microemulsification

area was determined and different formulations were prepared. Particle size, zeta

potential, dispersibility test and thermodynamic stability studies were measured. In-vitro

dissolution test of thermodynamically stable formulations OS-B and OS-C were carried and

results were compared with those of plain drug and suspension formulation. Stability

studies performed indicated that formulation OS-C remained stable over 12 months period.

Thus this investigation concluded that hydrophobic drugs like orlistat can be delivered

effectively through the formulation of SMEDDS.

Keywords: Dissolution; Orlistat; phase diagram; thermodynamic stability



Donga J, Surani V, Chauhan S, Aundhia C, Seth A.Formulation, and in-vitro

evalution of sustained release tablet of nifidipine using hydrophilic polymer.

Pharma Science Monitor. 2012;3(4).

Abstract

Conventional drug delivery system for treating the angina and hypertension are not much

effective as the drug do not reach the site of action in appropriate concentration. Thus an

effective and safe therapy of this angina and hypertension disorder using specific drug

delivery system is a challenging task to the pharmaceutical technologists. Most commonly

used method of modulating the drug release is to include it in a matrix system because of

their flexibility, hydrophilic polymer matrix systems are widely used in oral controlled

drug delivery to obtain a desirable drug release profile, cost-effectiveness, and broad

regulatory acceptance. Formulation of Nifedipine sustained release tablet was prepared by

the polymers blend with to get desirable release profile. Formulated tablets were also

characterized by parameters like thickness, weight variation test, drug content uniformity,

hardness, friability and the in-vitro drug release rate profile was compared with the

marketed product release profile with the help of similarity factor (f2) and difference value

(f1). Formulation prepared with HPMC K100M indicates 97.20% of drug release at 12 hrs

and it has similarity factor (f2) value 96.97 and difference factor (f1) value 0.59.

Hydrophilic polymer HPMC K100M showed 12 hrs release of Nifedipine drug.

Keywords: Nifedipine, HPMC K100M, Sustained release, Matrix tablets.



Gurjar NM, Seth A, Zanwar A, Patel J, Deshmukh G. Development of first

derivative spectroscopy method for estimation of budesonide and formeterol

in combined dosage form. Pharma Science Monitor. 2012;3(1).

Abstract

Sensitive, precise, accurate, and simple UV spectrophotometric methods have been

developed for simultaneous estimation of Budesonide (BUD) and Formeterol (FRL) in dry

powder inhaler dosage form. The method employed first order derivative spectroscopy in

which derivative amplitudes were measured at selected wavelengths (269.4 nm for BUD

and 284.6 nm for FRL). Linearity was observed in the concentration range of 2-26 µg/ml

for BUD and 10-100 mcg/ml for FRL. The method was found to be accurate (mean

percentage accuracy 100.07 )for budesonide and (mean percentage accuracy 100.06) for

formeterol and precise with %RSD 0.41 and 0.96 for BUD and FRL(API) respectively(for

intraday) and % RSD 0.42 and 0.84 for BUD and FRL (combined dosage form) respectively

(for intraday) and 0.78 and 0.48 for BUD and FRL (API) respectively (for inter-day) and

0.61 and 0.45 for BUD and FRL (combined dosage form) respectively (for interday). The

proposed methods have been applied successfully to the analysis of cited drugs in

pharmaceutical formulations. The methods were validated as per ICH guidelines.

Keywords: Budesonide, Formeterol, first order derivative spectroscopy.



Kumar P, Yadav AS, Kumar S, Yadav YC, Seth A, Jha V. Process validation of

pantoprazole sodium delayed release tablet usp 40 mg. Inventi Impact:

Pharmaceutical Process Development. 2012.

Abstract

In present work, concurrent process validation of Pantoprazole Sodium 40 mg delayed

release tablets was carried out to monitor process parameters in current production

batches. The process validation was divided into two major steps, first one is process

validation of dosage form before coating, and second one is after coating. In-process quality

monitoring of all critical processing steps was done for three production batches, before

coating and after coating. End product testing of current production batches was done to

provide documented evidence that manufacturing process is in state of control. Assay for

drug content was within the limit of 100%-104% at the dry mixing stage. LOD for the dried

granules after wet granulation was within 1-4% RSD. Assay after lubrication was within the

specified limit at different corners in the blender, indicating blend uniformity. Physical

parameters like average weight of core tablet was found to be 180.95%-182.25%,

thickness was found to be between 3.25 cm-3.60 cm, hardness was found to be

5.08kg/cm2-5.65kg/cm2, %friability was between 0.117%-0.134%. disintegration time

was 181sec -202 sec, assay of core tablets 99.54%-100.13 % for all the three batches of

compressed tablets. Two coatings were applied on the core tablets, base coating and

enteric coating. Base coating using OPADRY polymer and enteric coating using ACRYL EZE

polymer. Temperature monitoring was done throughout the coating process. After coating

percentage weight build up was within 10%-12%. Finished product assay was between

99.56%-100.23%. No dissolution of active occurred in acidic medium up to 2 hours, drug

release in buffered medium was within the limit of 96%-100% within 30 min. Average

weight of coated tablet was between 200.52mg-202.37mg. Diameter of coated tablets was

9.1mm- 9.19mm. Thickness was 3.97cm-3.99 cm. Uniformity of dosage forms for 10 dosage

unit is between 98.91%- 99.05%, which is within the acceptance limit of = 15 %. Blister

strip packing was carried out for the tablets. During packing operation each pack size was

checked for physical appearance and sealing quality and found satisfactory. All the tests



were found to have satisfactory results. Thus process validation of pantoprazole tablets

was successfully completed and found within the specifications.



Malik A, Kushnoor A, Saini V, Singhal S, Kumar S, Chand Yadav Y.

Analytical method development of nutraceutical: umbelliferone. Pharma

Science Monitor. 2012;3(1).

Abstract

Coumarins, an old class of compounds, are naturally occurring benzopyrene derivatives. A

lot of coumarins have been identified from natural sources, especially green plants.

Coumarins have attracted intense interest in recent years because of their diverse

pharmacological properties. Phytochemical investigation on the fruit of Aeglemarmelos

(Rutaceae) has resulted in the development of analytical method for Umbelliferone. The

present study was undertaken to develop a validated, rapid, simple, and low-cost

ultraviolet (UV) spectrophotometric method for estimating Umbelliferone in dosage

preparations. UV spectrophotometric analysis was performed spectrophotometrically at a

pre-determined λ_max of 324 nm with distilled water (using ethanol as co-solvent) as

diluent/blank. The method was validated for linearity, accuracy, precision, reproducibility,

and specificity as per International Conference on Harmonization (ICH) guidelines. The

method was also used in the determination of the content of umbelliferone in formulations

of umbelliferone. The regression data for the calibration plots exhibited good linear

relationship (R² = 0.9991) over a concentration range of 0.5– 6.5 μg/ml and the linear

Regression equation was y=0.169 x + 0.023. Mean recovery accuracy was 96.9 %, which

was not significantly different from the expected value (p = 0.05), while coefficient of

variation (CV) for both intra-day and inter-day was < 7 %. The method was specific for

umbelliferone in the presence of common excipients, and when it was applied to

formulations, umbelliferone content was 97.89 ± 3.08 and 99.05 ± 1.99 %, respectively, of

calculated claim. The proposed method gave good validation results and the statistical

analysis performed proved that the method is precise, accurate, and reproducible, and

hence can be employed for routine analysis of umbelliferone in bulk and commercial

formulations.

Keywords: Umbelliferone, Spectrophotometric method, Validation, Dosageformulations,

Quality control.



Mansuri M, Seth A, Molvi K, Prajapati B, Desai D. Synthesis and

pharmacological evaluation of some 3-(4-(substituted) 2-morpholino-4-yl-4-

phenyl-thiazole-5-carbonyl)-1-benzopyran-2-one. Pharma Science Monitor.

2012;3(2).

ABSTRACT

Taking in to consideration of diverse biological activities of coumarin and thiazole

derivatives, attempts have been made to attach a thiazole side chain at C-3 position of

coumarin. In addition, to expand the structural diversity of synthetic courmarins for

biological functions, the morpholine fusion at 2nd position of thiazole was also attempted.

The compounds MM3M1 were synthesized keeping coumarin-3-yl constant at fifth

position, morpholine at 2nd position and phenyl moiety at 4th position of thiazole nucleus.

The compounds MM3M2, MM3M3 and MM3M4 were synthesized keeping coumarin-3- yl

constant at fifth position, morpholine at 2nd position and introducing electron

withdrawing group (-Cl) at ortho, meta and para position respectively in phenyl moiety at

4th position of thiazole nucleus. All the synthesized compounds were evaluated for their

invitro antibacterial and anti-platelet activity. On the basis of structure-activity relationship

studies of synthesized MM3M1- MM3M4 it can be concluded that presence of 2-

chlorophenyl group at the 4th position of the thiazole contributes significantly to

antibacterial and anti-platelet activity profile of the candidates.

Keywords: Coumarin, thiazole, antibacterial activity, anti-platelet activity.



NathYadav S, Zanwar A, Katewa J, Seth A. Process validation of paracetamol

tablet.Pharma Science Monitor. 2012;3(3).

Abstract

In present work, concurrent process validation of Paracetamol Tablet 500 mg, good release

tablets was carried out to monitor process parameters in current production batches. In-

process quality monitoring of all critical processing steps was done for three production

batches, End product testing of current production batches was done to provide

documented evidence that manufacturing process is in state of control. Assay for drug

content was within the limit of 98%-102% at the dry mixing stage. LOD for the dried

granules after wet granulation was within 1.30-1.80%. Assay after lubrication was within

the specified limit at different corners in the blender, indicating blend uniformity. Physical

parameters like average weight of tablet was found to be 589.5mg-592.5mg, thickness was

found to be between 4.0mm-4.4mm, hardness was found to be 3.0kg/cm2 - 5.0kg/cm2 ,

%friability was between 0.25%-0.41%. Disintegration time was 3min -4min, assay of

tablets 99.4%-100.0 % for all the three batches of compressed tablets. Temperature

monitoring was done throughout the process. Dissolution occurred in buffer up to 30 min.

at-50 rpm. , drug release in buffered medium was within the limit of 95%- 98% within 30

min. Thickness was 4.09mm-4.24 mm. Uniformity of dosage forms which is found to be (98

% to 102%). Blister strip packing was carried out for the tablets. During packing operation

each pack size was checked for physical appearance and sealing quality and found

satisfactory. All the tests were found to have satisfactory results. Thus process validation of

paracetamol tablet 500mg was successfully completed and found within the specifications.

Keywords: Paracetamol Starch, Pyrolidone cellulose Magnesium Stearate & Talcum having

Good Release property, Process validation, Concurrent validation



Patel KM, Zanwar A, Kumar Sen A, Sahoo U, Seth A. Simultaneous

estimation of levofloxacin hemihydrate and ornidazole in tablet dosage form

by using simultaneous equations method. Pharma Science Monitor. 2012;3(1).

Abstract

The simple, accurate, precise, reproducible and economical procedure for simultaneous

estimation of Levofloxacin hemihydrate and Ornidazole in tablet dosage form as well as in

bulk drugs have been developed using double beam UV Spectrophotometer. The method

based on solving of simultaneous equation using 289 nm (λmax of LEV) and 320 nm (λmax

of ORN) as two analytical wavelengths for both drugs. The solution of both drugs was

prepared using Distilled water as a solvent. The proposed method is suitable for

simultaneous determination of Levofloxacin hemihydrate and Ornidazolein pharmaceutical

dosage form.

Keywords: levofloxacin hemihydrate, ornidazole, Simultaneous equation method.



Patel Y, Sen A, Shah B, Seth A. Development and validation of new analytical

method for quantitative estimation of racecadotril as an active phamaceutical

ingredient by rp-hplc. Pharma Science Monitor. 2012;3(4).

Abstract

A simple and sensitive spectroscopic method was developed for the estimation of

Racecadotril in pharmaceutical dosage forms. Spectroscopic method is showing absorbance

at 231 nm in methanol. This method obeys Beers law in the concentration range of 8 to100

μg mL-1 respectively. The proposed method is precise, accurate and reproducible and can

be extended to the analysis of Racecadotril in bulk and tablet formulations. The

quantitative determination of the drug was carried out using the second-derivative values

measured at 223, 250 and 273 nm and Third-derivative spectrum values measured at

226and 240nm.Calibration graphs constructed at these wavelengths were linear in the

concentration range of 8-100µg mL-1 for secondderivative and third-derivative

spectrophotometry method. A HPLC assay utilized Phenomenex-Luna RP-18(2)

(250X4.6mm, 5 mm) column, with mobile phase composition of Acetonitrile: 0.05M

phosphate buffer (Potassium dihydrogen orthophosphate): triethylamine [80:19.95:0.05,

(v/v/v)] of pH 3.953 ± 0.2 was used, and flow rate was 1.0 ml min-1 with UV detection at

231 nm. Atorvastatin calciumvastatin calcium (ATOR) was used as internal standard. The

retention time of Racecadotril and ATORVASTATIN CALCIUM were 4.22 and 3.453 min

respectively. The total HPLC run time was less than 6 min. Linearity was observed over

concentration range of 8-80 µg ml-1 for Racecadotril. The proposed method was validated

for various ICH parameters like linearity, limit of detection, accuracy, precision,

ruggedness, robustness, and system suitability.

Keywords: Racecadotril, Validation, RP-HPLC method.



Prajapati B, Seth A, Molvi K, Mansuri M, Desai D. Synthesis of some novel 2-

substituted nitroimidazole as potent anti-anaerobic agent. Pharma Science

Monitor. 2012;3(2).

Abstract

The nitroheterocyclic compounds have proved to be very effective antimicrobial agents

and very valuable member of limited armamentarium of antiprotozoal agents. A number of

5-nitoimidazole with substitution at 2-position with various substitutent are found to

modify the antibacterial spectrum. Some 2-substituted nitroimidazole analogues were

designed, synthesized and characterized. The synthesized compounds were tested for their

antibacterial sensitivity against Gram-positive anaerobe (C. sporogenus) and Gramnegative

anaerobe (B.fragilis) using macro broth dilution method. All the synthesized compounds

exhibit good activity at 10 mcg/ml against Gram-negative anaerobe compared to standard

control tinidazole and metronidazole, while remain inactive against Gram-positive

anaerobe.

Keywords: nitroimidazole, reduction, acid chloride, macro broth dilution.



Prajapati B, Seth A, Molvi K, Rathod I, Suhagia B, Mansuri M, et al.

Extended huckel partial atomic charges of nitroimidazole and prediction of

dna damage. Pharma Science Monitor. 2012;3(2).

Abstract

Nine nitroimidazoles drugs representing different class were found in the literature to have

their respective half wave potential and one electron reduction potential measure under

near-identical conditions. The structures of these nine nitroimidazoles were optimized, and

resulting physicochemical parameters were regressed against one electron reduction

potential (OERPs). A very significant linear correlation (QSAR) was found between OERPs

and Extended Huckel Partial Atomic Charges. These findings suggest that it may be possible

to estimate OERPs of nitroimidazole in advance to its synthesis. Insofar as the OERPs

correlating to DNA damage, radiosensitization efficiency, aerobic cytotoxicity, mutagenicity

and hypoxic cytotoxicity; the Extended Huckel Partial Atomic Charges can predict well all

these biological activity prior to synthesis of novel nitroimidazoles.

Keywords: One electron reduction potential, nitroimidazole, partial charge, half wave

potential.



Shrey S, Ghelani T, Shah N, Seth A, Deshmukh G, Chauhan S, et al.

Formulation and in vitro evalution of sustained release tablets of

clomipramine hydrochloride. Pharma Science Monitor. 2012;3(1).

Abstract

Current state of art is witnessing a revolution in new techniques for drug delivery.

Nevertheless, convenience of manufacturing and patient compliance has maintained their

significant importance in the design of drug delivery systems. The objective of the project

was to develop a stable and robust formulation of the clomipramine hydrochloride. The

present study deals with evaluation and optimization of various critical formulation and

process variables of oral solid sustained release dosage form, containing an antidepressant

clomipramine hydrochloride drug. Clomipramine was having extensive 1st pass

metabolism and associated with frequent dosing of conventional dosage form makes it a

suitable candidate for sustained release dosage form for patient compliance. For present

work, eudragit having different grades like RL 30D, RS 30D were selected as release

retarding agent. Matrix system of clomipramine hydrochloride based on hydrophobic

polymer (eudragit RL 30D, eudragit RS 30D, etc.) was tried individually as well as in

combinations. Finally core tablets were coated using HPMC 6 Cps. Final optimized batches

(F011) obtained fulfilled the criteria of significantly retard the release up to 24 hours with

initial loading dose release. Thus it was considered as the optimized batch for once a day

sustained release tablet formulation containing clomipramine hydrochloride.

Keywords: Clomipramine hydrochloride, eudragit RL 30D, eudragit RS 30D, HPMC 6Cps,

sustained release tablets.



Surani VS, Donga JJ, Chauhan S, Ghelani T, Seth A, Shah N, et al. Design,

development and evaluation of the hydrodynamically balanced tablets of

ciprofloxacin hydrochloride. Pharma Science Monitor. 2012;3(1).

Abstract

Ciprofloxacin HCl has an absorption window in the stomach and in the upper part of the

small intestine. The present investigation concerns the development of hydrodynamically

balanced tablets of ciprofloxacin, which are designed to prolong the gastric residence time

and thereby increase drug bioavailability after oral administration. Five different batches of

tablets were fabricated containing Ciprofloxacin, polymers like HPMC K4M, HPMC K15M

and Chitosan, along with gas generating agent sodium bicarbonate. The physicochemical

properties of different formulations, their buoyancy lag time, total floatation time and

swelling index were evaluated. It was found that the hardness of the tablet will affect the

buoyancy characteristic of the dosage form. The in vitro release studies (USP XXIII)

indicated that the floating dosage forms containing HPMC K15M showed slower release

and the integrity of the device was maintained. The % drug release profile was found in the

order of F2 > F3 > F6 > F1 > F5 > F4. The in vitro release data was treated with

mathematical equations, and it was concluded that release of ciprofloxacin from the tablet

follows Peppas model with non-Fickian diffusion. F2 formulation showed better control of

drug release with comparison to marketed product. Finally the results had proven that the

gas powered Hydrodynamically Balanced Tablets of ciprofloxacin containing HPMC K15M

provides a better option for controlled release action and improved bioavailability.

Keywords: Gastric residence; Gas generation; Swelling index; Ciprofloxacin.



Tank P, Zanwar A, Seth A, Kumar S. Development of new analytical methods

for quantitative estimation of racecadotril as an active pharmaceutical

ingredien by uv spectrophotometer. International Journal of Pharmaceutical

Sciences and Research. 2012;3(5):1495.

Abstract

A simple and sensitive spectroscopic method was developed for the estimation of

Racecadotril in pharmaceutical dosage forms. This method is based on Racecadotril,

showing absorbance at 231 nm in methanol. This method obeys Beers law in the

concentration range of 8 to 100 Âµg mL-1 respectively. The proposed method is precise,

accurate and reproducible and can be extended to the analysis of Racecadotril in bulk and

tablet formulations. The method was linear (r=0.9998) at concentrations ranging from 8 to

100 Âµg ml-1, precise (repeatability and intermediated precision), exact (method of

standard addition), and Limit of detection Âµg ml-1 (0.088749). Limit of quantification Âµg

ml-1 (0.268938) was found and the % recovery is found 99.69%.

Keywords: Racecadotril, Validation, UV spectrophotometer method.

Department of Pharmacy 2012 - Sumandeep …...Formulation & development of Bilayer tablet of...

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