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  • A REVIEW ON USFDA WARNING LETTER AND VIOLATION OBSERVED IN PHARMACEUTICAL INDUSTRY

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    ABOUT AUTHORS
    Suleman S. khoja 1, Sohil S khoja
    1,Parthkumar H chauhan 2,Farhad S Khoja
    1Resource person in pharmaceutical quality assurance ,VAPI, Gujarat.
    2Resource person in quality assurance ,NAVSARI, Gujarat.
    3Registered Pharmacist ,VAPI, Gujarat.
    premukhoja@gmail.com

    ABSTRACT
    A review on USFDA observation and finding while inspection of Pharmaceutical the present review provide some important , Significant observation and measure of compliance.USFDA is an regulatory body governing health products which are made ( in or  outside USA) and marketed in united States of America. Significant deviation from cGMP and Significant violation from cGMP for both API Facility and formulations .strictly compliance requirements under 21 Code of federal regulations (CFR). FDA observation includes but not limited to this. If not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the Safety, Identity, Strength, Purity and Quality of drug product (SISPQ) ,violation under [ 21 CFR & 211.67 (a) ]. Data integrity is main issue Raised in most FDA warning letter. Corrective action and plan. Level of control must be raised from raw material, packaging material (Accurate, Legible, Contamptarious, Original, Attributable (ALCOA)) in process, finished dosage form, Maintain log book properly. Guidelines for Out of specification(OOS ) and out of trends(OOT)  must be follow if any required.

  • A COMPARATIVE STUDYOF CENTRAL ANALGESIC ACTIVITY OF POTENTIAL ANTIDEPRESSANTS

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    ABOUT AUTHORS
    S. VISWANTH REDDY*, G.AVINASH1, R. SAGAR2
    PNR College of Pharmacy,
    Shadnagar, Mahaboob Nagar (Dist), Telangana
    vishwanth555@gmail.com

    ABSTRACT
    Pain is an ill defined, disabling accompaniment of many medical conditions. It is often evoked by an external and internal noxious stimulus. It affects millions of people suffering with depression and other psychiatric disorders. Most of the antidepressants are having analgesic capacity to treat the pain by inhibiting nociceptive stimuli by increasing the seratonergic and noradrenergic transmission in CNS.

    Objectives
    The Present study carried out to investigate the central analgesic activity of potential antidepressants like Fluoxetine, Imipramine, Amitriptyline and to compare the analgesic activity with standard central analgesic Pentazocine.

    Methods
    Analgesic activity was evaluated by using hot plate and tail immersion models in mice. Fluoxetine (10 mg/kg), Imipramine (20 mg/kg), Amitriptyline(20 mg/kg) were used as test drugs and Pentazocine (10 mg/kg) was used as standard drug. 

    Results
    In tail immersion model of analgesic activity Fluoxetine possess significant analgesic activity (*p<0.05 at 60 min interval, ***p<0.001 at 90 and 120 min interval) Amitriptyline also showed significant analgesic activity (**p<0.01) at 90 min interval and ***p<0.001 at 120 min interval. Imipramine is the least effective analgesic in this study showed mild analgesic activity (*p<0.05 at 90 min interval and **p <0.01 at 120 min interval).

    In hot plate analgesic model Fluoxetine and Amitriptyline possess significant analgesic activity (***p<0.001 at 120 min interval), Imipramine same like above said model less effective, doesn’t shown significant analgesic activity.

    Conclusion
    All the test drugs significantly reduce the painful stimuli when compared to the control group in both the models. These results suggest that the antidepressants which increase the monoamine transmission in the brain posse’s significant antidepressant activity and might be useful as potent analgesics.

  • EVALUATION OF DOOR TO NEEDLE TIME AND PREDISPOSING FACTOR TO IT IN A TERTIARY CARE HOSPITAL, CHIDAMBARAM

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    ABOUT AUTHORS
    ALEEM SARWAR*1, ADHIN ANTONY XAVIER1, K RAGACHANDANA1, C K DHANAPAL1, S SUDARSHAN2
    Department of Pharmacy1, Annamalai University, Chidambaram, Tamil Nadu, India
    Department of Medicine2, Rajah Muthiah Medical College, Annamalai University, Chidambaram, India
    aleempharma30@gmail.com

    ABSTRACT
    OBJECTIVE

    The aim of our study is to evaluate the door to needle time for ST-segment elevation myocardial infarction and to identify factors associated with a prolonged door to needle time. STEMI most commonly occurs when thrombus formation results in complete occlusion of major epicardial coronary vessels. Percutaneous coronary intervention and Thrombolytics are the two choice of treatment available for STEMI. Where door to needle time have a significant role in determining the efficacy of thrombolytics.

    METHODOLOGY
    This is a prospective observational study conducted at RMMCH hospital, during the period of Nov 2014 to March 2015, all patient admitted with STEMI, who were thrombolysed were included in the study. Door to needle time is measured and reason for prolongation is identified. Patients who were diagnosed as NSTEMI or unstable angina and who were diagnosed as STEMI and not thrombolysed were excluded from the study.

    RESULT
    100 patients were included in the study. Which comprises of 72 males and 28 females .door to needle time of < 30 minute was achieved in 27% of study population as per ACC/AHA guidelines were 73% failed to achieve. Highest number of population was observed in the age group of 61-70 which consist of 21 males and 6 females. Mean door to needle time was found to be 44 minutes. Majority of the patients were thrombolysed in between 31 – 45 minutes

    CONCLUSION
    less than a third of patients with STEMI received thrombolytics within the prescribed time interval of 30 minutes. Delay in decision making and lack of senior medical officers was found to be predisposing factor for the prolongation of door to needle time ,which requires special attention.

  • EVALUATION OF ANTIBACTERIAL ACTIVITY OF MOMORDICA CHARANTIA

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    ABOUT AUTHORS
    Deepak Ku. Birla*
    Shri Bherulal Pharmacy Institute
    Indore, Madhya Pradesh, India
    deepakbirla7@gmail.com

    ABSTRACT
    Momordica Charantia is the widely consumed fruit in India. The seeds, fruit, leaves, and root of the plant have been used in traditional medicine for microbial infections, sluggish digestion and intestinal gas, menstrual stimulation, wound healing, inflammation, fever reduction, hypertension and have many significant other medicinal effects. Various phytochemicals present in leaves are extracted using soxhelt apparatus with different solvents. The aim of the study is to assess the antibacterial activity and to determine the zone of inhibition of extracts on some bacterial strains. The antibacterial activity was checked against different human pathogens. The antibacterial activity was determined in the extracts using Disc diffusion method. The present study discusses antibacterial activity of Momordica Charantia extracts. Antibacterial activity was tested against (Pseudomonas aureogenosa, Staphylococcus aureus, Staphylococcus epidermis, Shigella flexineri, Bacillus substilis & E.Coli.). The results showed that the remarkable inhibition of the bacterial growth was shown against the tested organisms.

  • 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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