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  • QUALITY BY DESIGN (QbD) IN PHARMACEUTICAL INDUSTRY: TOOLS, PERSPECTIVES AND CHALLENGES

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    ABOUT AUTHORS
    Arijit Gandhi*1, Chandrani Roy2
    1 Production cum Quality Manager, Kras Pharmaceuticals Pvt. Ltd., Fatwah, India.
    2 Department of pharmaceutics, Gupta College of Technological Sciences, West Bengal
    arijit.babugandhi.gandhi@gmail.com

    ABSTRACT
    Recently the concept of “Quality by Design” (QbD) gaining much attention among pharmaceutical industries for maintaining Quality. It serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based, holistic and proactive approach for development of pharmaceutical product. It mainly covers designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include defining target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability & controlling manufacturing processes to produce consistent quality over time The purpose of this article is to discuss the concept of pharmaceutical Quality by Design and describe how it can be help to ensure pharmaceutical quality & drug development.

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  • EFFECTIVE PRECEPTING TO ENHANCE COMMUNICATION SKILLS OF PHARMACY STUDENTS

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    ABOUT AUTHORS
    Srinivasa Babu Puttagunta, Sowjanya Pulipati, Sai Koushik Oruganti
    Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh
    kaushikoruganti555@gmail.com

    ABSTRACT
    Introduction: Clinical pharmacists work directly with doctors, health professionals and patients to ensure that the medications prescribed for patients contribute to the best possible health outcomes. Therefore, pharmacy students should be given opportunities to learn and practice interpersonal communication skills.

    Objectives: This observes opinions the position of the pharmacist preceptor in facilitating improvement of conversation capabilities for students participating in community in community advanced pharmacy practice experiences.

    Material and methods: Preceptors need to set a stage to comprise precepting into the workflow and to offer green and effective teaching opportunities. College students ought to go through practical activities like affected person counseling  and participating in collaborative work with health care professionals. Preceptors should incorporate the teaching in a lively and demonstrative way for a better impact on their students.
    Results and discussion: By following a strategic approach in the methods of teaching the preceptors can effectively and likely enhance the communication skills of the students.

    Conclusion: The incorporation of communication skills to pharmacy practice can positively impact the pharmacy site, preceptor, student and more importantly patient.

  • ANTIEPILEPTIC ACTIVITY OF MURRAYA KOENIGII LEAF EXTRACTS

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    ABOUT AUTHORS
    JA Sathwara1*, AM Bhandari2
    1Department of Pharmacology,
    A.R.College of Pharmacy & G.H.Patel Institute of Pharmacy, V.V. Nagar, Anand, Gujarat.
    2Department of Clinical Pharmacy,
    A.R.College of Pharmacy & G.H.Patel Institute of Pharmacy, V.V. Nagar, Anand, Gujarat.

    *jignasa.sathwara@gmail.com

    ABSTRACT
    The aim of the present study was to investigate antiepileptic effect of the aqueous extract of the leaves of Murraya koenigii L. Spreng (AEMK) on electrically and chemically induced seizures. The aqueous extract of the leaves of M. koenigii (200 and 300 mg/kg) were studied for its antiepileptic effect on maximal electroshock induced seizures and pentylenetetrazole induced seizures in mice. AEMK (200 and 300 mg/kg) significantly reduced the duration of seizures induced by maximal electroshock (MES) as well as protected animals from pentylenetetrazole induced tonic seizures. The results suggest that the aqeous extract of the leaves of M. koenigii may produce its antiepileptic effects via non-specific mechanisms since it reduced the duration of seizures produced by maximal electroshock as well as delayed the latency of seizures produced by pentylenetetrazole.

  • SPECIFICATIONS FOR STARTING MATERIALS, INTERMEDIATES AND FINISHED PRODUCTS

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    ABOUT AUTHORS
    Nirav R.Soni, M.Pharm
    A-one Pharmacy college,Enasan
    Dept.of Qualtiy Assurance (QA)
    nirav_sonic@yahoo.com

    ABSTRACT
    The specifications are to assure that each unit has the value of drug claimed on the label, that all the drug in each unit is out there for whole use ,that the drug steady  within the formula in its certain final container for their expected shelf life and it’s having no toxic overseas substance. It’s greatly utilized in pharmaceutical enterprise and utilized by using wellness sector and support best which is finished via GMP, GLP and GCP and other organization including Pharmaceutical Quality System (PQS) , Quality Risk Management (QRM)  and Quality by Design (QbD).

  • A Review on chemistry and Pharmacological activity of Cinnarizine and Dimenhydrinate combine dosage form

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    ABOUT AUTHORS
    Suleman S. khoja, Parthkumar H. Chauhan, Maulik N. Patel, Harsha D. Jani
    Department of Quality Assurance,
    Shivam Pharmaceutical Studies and Research Centre, Anand, Gujarat.
    premukhoja@gmail.com

    ABSTRACT
    Cinnarizine and Dimenhydrinate combination are active contain and approved by CDSCO The two substances belong to different groups of medicines. Cinnarizine  is a part of a group called calcium antagonists.  Dimenhydrinate belongs to a group called antihistamines Also used in Treatment of vertigo symptoms of various origins. exhibits  anti-emetic and antivertiginous  effects through  influencing the chemoreceptor trigger zone in  the  region of the  4th  ventricle.  Dimenhydrinate thus  acts  predominantly on the central vestibular system.  Due to  its calcium  antagonistic properties, cinnarizine acts  mainly  as a vestibular sedative  through inhibition  of  the calcium  influx  into  the vestibular  sensory cells. Cinnarizine thus acts predominantly on the peripheral vestibular system. Both  cinnarizine and  dimenhydrinate  are  known  to  be effective in  the treatment  of  vertigo.  The combination product is more effective than the individual compounds in the population studied.  The product has not been evaluated in motion sickness. Maximum plasma  concentrations  (Cmax)  of  cinnarizine  and diphenhydramine are reached in  humans  within  2  - 4 hours. metabolised  in  the liver. Cinnarizine is  mainly eliminated  via the  faeces (40-60%) and to a lower extent also in  urine, mainly in the form  of  metabolites conjugated  with  glucuronic acid.  The major route  of  elimination  of diphenhydramine is in  the urine

  • A COMPARATIVE PHARMACOLOGICAL STUDY OF DIURETIC DRUGS

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    ABOUT AUTHORS
    Bharat Lal Naik, Chaitanya Prasad Meher
    Department of Pharmacology
    The Pharmaceutical College (TPC), Tingipali, Barpali, Odisha
    chaitanyameher84@gmail.com

    ABSTRACT
    Diuretic are the drugs that promote the output of urine excreted by kidney. The increased excretion of water & electrolytes by the kidney is dependent on 3 different process viz. glomerular filtration, tubular reabsorption & tubular secretion. Diuretic are very effective in the treatment of cardiac oedema, specifically the one related  with congestive heart failure(C.H.F). They are extensively used in various type of disorders for ex. Cirrhosis of liver, Hypertension,Nephritic syndrome, diabetes insipidus, nutritional oedema, oedema of pregnancy & also to lower intraocular & cerebrospinal fluid pressure. The presented article is based on comprehensive idea about the pharmacology of various diuretic drugs.

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  • A comparative evaluation of the quality & price of generic medicine with their branded counterparts

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    ABOUT AUTHORS
    Bhupender Singh, Arun Nanda, Vikaas Budhwar, Rakesh K. Marwaha
    Department of Pharmacy,
    M. D. University, Rohatak
    Haryana, India

    * pharma.bsingh@gmail.com

    ABSTRACT
    Generic drugs are as effective as their branded counterparts in terms of safety and efficacy. Although their exists several myths about quality of generic medicines because of its less price as compared to branded counterparts. The present study aims to evaluate and compare the quality of generic medicine with their branded counterparts as per Indian Pharmacopoeial standards and other validated methods on a commonly used type 2 diabetes drug (Metformin). The qualitative as well as quantitative studies were performed as per IP 2010. The official test performed includes uniformity of weight, disintegration, dissolution, assay and friability. Non official test includes hardness test and assay by HPLC using validated methods. The study revealed that branded as well as generic metformin tablets comply with the standards provided in IP 2010 and generic metformin was found to be 111.52% lesser in cost per tablet as compared to costliest branded version of metformin.

  • COMPARATIVE STUDY OF PHARMACOGNOSTICAL AND PRELIMINARY PHYTOCHEMICAL INVESTIGATION OF CURCUMA LONGA LEAVES AND RHIZOMES

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    ABOUT AUTHORS
    Seema*, Parminderjit Kaur
    Department of Pharmacy,
    Rayat Bahra Institute of Pharmacy, Hoshiarpur, Punjab, India
    *seemakumar2125@gmail.com

    ABSTRACT
    Turmeric (Curcuma longa) is a perennial herb, belonging to family Zingiberaceae. The rhizomes and leaves of turmeric were extracted separately with ethanol by Soxhlet extraction and the percentage yield of rhizomes and leaves of Turmeric was 12% and 17% yield respectively. The extract of turmeric rhizomes and leaves can increase the bile flow, offer protection of the gall bladder and also the leaf extract possess anticancer properties. The present study was focused on the isolation of curcuminoids by thin layer chromatography using chloroform: ethanol: glacial acetic acid in a ratio of 95: 5: 1. From TLC the better resolution of Rf value was observed in rhizomes at 0.8, 0.66, 0.51 as Curcumin, Demethoxycurcumin, Bisdemethoxycurcumin respectively whereas Rf value of leaves was 0.42 as Bisdemethoxycurcumin, when visualized under 366nm under bright yellow fluorescent. The phytochemical screening of leaf extracts showed the presence of flavonoids, cardiac glycosides and phenols. The ash value of turmeric rhizomes and leaves was 3.33% and 6.67%, acid insoluble value was 1.3% and 2% and water insoluble value was 13.3% 1nd 16.67% respectively. The moisture content of rhizomes and leaves of turmeric in IR- Moisture balance was found to be 0.93 and 0.30 whereas in Tray Drier the moisture balance was 0.46 and 0.27 respectively while the melting point was observed as 160-1630C and 116-1200C respectively which resembles the report of literature (IP, 2007).

  • SPECTROSCOPIC PARALLELISM IN STRUCTURAL SKELETONIZATION AND STANDARDIZATION OF PHARMACEUTICALS

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    ABOUT AUTHORS
    Nisha Sharma1, Mohammad Arshad2, Asif Jafri2, Deepak Chowrasia*1
    1Institute of Pharmacy, Chhatrapati Shahu Ji Maharaj University,
    UP, Kanpur, India.
    2Molecular endocrinology lab, Department of Zoology, Lucknow University, (U.P.), Kanpur, India.
    *chowrasia.deepak@gmail.com

    ABSTRACT
    Spectroscopy based pharmaceuticals chemofingerprinting and standardization is an essential intent to portrait molecular structures as well, a cemented platform to harvest diversified physiochemical characteristics of therapeutic chemoentity. Compared to classical wet techniques, the spectroscopic-framed-chemical analysis meritoriously distinguished from former in terms of sensitivity, accuracy, precession, rapidness, detection limit, spectrum, versatility, result reliability, intuiting data, and automated operation. Quest for “ideal medicine” is still a misnomer, however, may comply if being assisted with well planned and excellently executed spectroscopy methodology. The present paper is design to explore various prospective of different spectroscopic technique and their role in chemical evaluation and standardization of pharmaceuticals.

  • QUANTITATIVE ESTIMATION OF SECONDARY METABOLITE AND INHIBITORY EFFECT OF AZIMA TETRACANTHA LEAVE EXTRACT AGAINST CANDIDA ALBICANS

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    ABOUT AUTHORS
    SANDHIYA.V*1, KAVITHA.C2
    1 Department of Pharmaceutics, C.L.Baid metha College Of Pharmacy, Thoraipakkam, Chennai, India
    2 Department of Pharmacognosy, C.L.Baid Metha College Of Pharmacy, Thoraipakkam, Chennai, India
    *sandhiyavaithi@gmail.com

    ABSTRACT
    The leaves of Azima tetracantha belongs to salvadoraceae family, commonly known as “mulluchangu” in tamil, it is a best known medicinal plant from ancient period. The plant has reported for many pharmacological action such as antifungal, antibacterial, hepatoprotective, anti inflammatory, anti ulcer, anti arthritic, hypolipidemia etc. The present study was investigated about the characteristics, quantitative estimation and antifungal activity of Azima tetracantha leave in different solvents extract (hexane, chloroform, ethanol, ethyl acetate and water) successfully. In quantitative estimation the leaves of Azima tetracantha shows 48.4 % yield of carbohydrate in water extract, 21%  yield of phenol in ethanol extract and 24%  in ethyl acetate extract and 19% yield of tannin in ethanol extract. In antifungal activity of Azima tetracantha leave two standard drugs are used such as clotrimazole (10 mcg/m1 as standard-1) and ketaconazole (10 mcg/ml as standard -2). The antifungal activity was studied for all extracts in a concentration of 100 mcg/ml, 200 mcg/ml and 400mcg/ml against Candida albicans and Aspergillus niger. The Ethanol extract of a leave of Azima tetracantha in increasing concentration shows prominent activity against Candida albicans compared to other extract. The Hexane, Chloroform and Water extracts of a leave of Azima tetracantha shows moderate activity against Candida albicans compared to ethyl acetate extract. The Ethyl acetate extract shows slight activity against Candida albican scompare to other extracts. There was no activity was observed for various extracts of Azima tetacantha against Aspergillus niger.

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