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  • IMPACT AND MANAGEMENT TOOL FOR IDENTIFICATION AND REDUCTION OF HUMAN ERRORS IN PHARMACEUTICALS INDUSTRY

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    ABOUT AUHTORS
    Suleman S. khoja 1 , Sohil S. khoja 1,
    Farhad S. Khoja 2,Shamim Khoja2,Narmin Pirani2

    1)Resource person in pharmaceutical quality assurance and Audit Compliance,VAPI 2) Registered Pharmacist , Gujarat
    Suleman salim khoja
    Email: premukhoja@gmail.com

    Scope 
    Human Error is commonly defined as “a failure of a planned action to achieve a desired outcome”. GMPs clearly state in CFR 211.22 that “[the quality control unit has]…the authority to review Production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.” Let’s analyze this statement. If the FDA expects that errors be fully investigated, it is safe to assume that the term error is NOT a root cause. That’s why it needs to be fully investigated, hence determine the root cause of the human error.  In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations. review article accurately how to accurately identify human errors, determine when a deviation or nonconformance requires CAPA, and get started using human performance improvement tools and processes in your organization.

  • BASICS OF AGING THEORIES AND DISEASE RELATED AGING - AN OVERVIEW

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    ABOUT AUHTORS
    Abhijit De*, Chandan Ghosh
    Department of Pharmaceutical Science,
    Bengal School of Technology, Sugandha,
    Hooghly, West Bengal, India
    * abhi8981@gmail.com

    ABSTRACT
    Aging is characterized by a progressive loss of physiological integrity, leading to impaired function and increased vulnerability to death. This deterioration is the primary risk factor for major human pathologies including cancer, diabetes, cardiovascular disorders, and neurodegenerative diseases. In this review, several theories and mechanisms have been put to explain the molecular basis of aging. For example, random damage of the DNA of somatic cell is believed to accumulate with increasing age. Free radicals produced during oxidation of metabolites for energy production also damage DNA and proteins.

  • SOLID DISPERSION- A REVIEW

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    ABOUT AUTHORS
    Bhumika Kumar*
    Department of pharmaceutics,
    Delhi pharmaceutical sciences and research university,

    New Delhi, India

    ABSTRACT
    Solid dispersion is an effective way of improving the dissolution rate of poorly water soluble drugs and hence its bioavailability.  The water soluble carriers used in preparation of solid dispersion enhance the dissolution rate of the poorly water soluble drug. The review article focuses on the methods of preparation, advantages, disadvantages and characterization of the solid dispersions.

  • VALIDATION-IN PHARMACEUTICAL INDUSTRY : CLEANING VALIDATION - A BRIEF

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    ABOUT AUHTORS
    Jaha Sultana Mohammed
    Pelcat Formulation PVT
    sohnivya786@gmail.com

    ABSTRACT
    The purpose of cleaning validation is to establish the documented evidence with high degree of assurance that the cleaning process followed as per standard operating procedure for cleaning the equipment used for the processing, consistently and concurrently yields the results not exceeding predetermined acceptance limit. The main objective of this particular study is to develop some understanding for the process of validation and its type along with importance of cleaning validation in pharmaceutical industry to prevent cross contamination. This topic includes Types of validation, cleaning validation, Levels of cleaning Validation, Cleaning mechanisms, cleaning agents used and process followed by pharmaceutical industry to achieve cleaning validation. The various methods used for cleaning validation are clearly discussed in this review.

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  • THERAPEUTIC GASES PHARMACOLOGY AND IT’S ADVANCED DELIVERY

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      ABOUT AUHTORS
    AKASH S MALI1,2*,AUDRIUS MARUŠKA2
    1University of Würzburg Germany.
    2Vytautas Magnus University, Lithuania
    *Akashmit97@gmail.com

    ABSTRACT
    Pharmaceutical gases molecules (Therapeutic medical Gases) are plays vital role in various disease conditions. In particular, Carbon monoxide, Oxygen, Nitric oxide, Hydrogen sulfide are generated in the human body and mediate signaling pathways as biological messengers and shown pharmacological effects on cardiovascular disorders, nervous system, respiratory track and gastrointestinal disorder. Appropriate oral delivery of gases is challenging concept in front of novel drug delivery system, recently microbubbles, nanobubbles, liposomes, ultrasound technology provides new oral and parenteral delivery platform for therapeutic gases. This review provides pharmacological effects of therapeutic medical gases and its novel delivery aspects.

  • STRUCTURE BASED ANTIBACTERIAL ACTIVITY OF 1,3-DIARYL-2-PROPEN-1-ONES AND THEIR RECENT PHARMACOLOGICAL INTERESTS

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    ABOUT AUHTORS
    Nisha Sharma, Mahroz, Deepak Chowrasia*
    University Institute of Pharmacy,
    Chhatrapati Shahu Ji Maharaj University, Kanpur, U.P.,  India

    chowrasia.deepak@gmail.com

    ABSTRACT
    Chemically chalcones are 1,3–diphenyl-2-propene-1-one, containing dual aromatic rings which are linked to each other via carbon bridge system enveloping keto-ethylenic core structure. Owing to the presence of conjugated double bond and electron dense aromatic ring system, the molecule posses less redox potential; thus greater probability for characteristic electron transfer reactions. Naturally, conjugated systems of these types are abundantly present in edible plants and are considered to be precursors of bioactive flavonoids and bioflavonoids. Chalcones and their derivatives find numerous industrial applications such as artificial sweeteners, scintillator, polymerization catalyst, fluorescent whitening agent, organic brightening agent, stabilizer against heat, visible light, and ultraviolet radiation.  As a chemo-identifying agent, chalcones have been found useful in elucidating structure of natural products like hemlock, tannin, cyanomaclurin, ploretin, eriodictyol and homoeriodictyol, and naringenin. Pharmacologically, the same molecule acts as a versatile and universally accepted moiety for design and development of numerous bioactive synthetic analogues in search of ideal medicine to conquer human pathological conditions.  The present paper thus designs to explore and study various prospective of chalcones and their derivatives in terms of recent developments and pharmacological importance.

  • A REVIEW ON GASTRO-INTESTINAL DRUG ESOMEPRAZOLE

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    ABOUT AUHTORS
    MNL Aishwarya, E. Anka Rao, M. Niranjan Babu
    Department of Pharmaceutics
    Seven Hills College of Pharmacy, Tirupati, AP, India
    meenumakkhan@gmail.com

    ABSTRACT
    Esomeprazole is a proton pump inhibitor used to treat gastric problems mainly peptic ulcers. Peptic ulcers are present in around 4% of the population. They newly began in around 53 million people in 2013. About 10% of people develop a peptic ulcer at some point in their life.They resulted in 301,000 deaths in 2013 down from 327,000 deaths in 1990. The first description of a perforated peptic ulcer was in 1670 in Princess Henrietta of England. H. pylori was first identified as causing peptic ulcers by Barry Marshall and Robin Warren in the late 20th century, a discovery for which they received the Nobel Prize in 2005. Esomeprazole comes under non-surgical treatment for peptic ulcers. Though it is an effective drug used for the treatment of peptic ulcers it includes some side effects such as headache, nausea, diarrhea, decreased appetite…etc., optical isomer of omeprazole is called as s-isomer of omeprazole or esomeprazole which is an improved form of omeprazole. Esomeprazole in combination with cardiovascular drugs produces potential interactions and positive effects. This review article provides an evaluation of the literature on the concomitant use of esomeprazole available. The efficacy, safety, tolerability, cost effectiveness, and patient quality of life of this regimen is discussed. A summary of the pharmacokinetic and pharmacodynamic interactions of esomeprazole, Mechanism of action of omeprazole, as well as its effects during pregnancy are also reviewed.

  • 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.

  • CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY - AN OVERVIEW

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    ABOUT AUTHORS
    Sadanand Maurya*1, Devendra Goyal2, Chandan Verma1
    1 Department of Quality Assurance in Macleods Pharmaceutical Limited
    2 Department of Production in Macleods Pharmaceutical Limited
    *sadanandmpharma@gmail.com

    ABSTRACT
    Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. In this article cleaning validation and cleaning validation program discussed in brief.

  • EPILEPSY: A BRIEF REVIEW

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    ABOUT AUTHORS
    Abdul Waheed*, Swati Pathak, Roohi Mirza
    Department of Pharmacology,
    Amity Institute of Pharmacy,
    Amity University, Noida, U.P., India
    *abdul.waheed2050@gmail.com

    ABSTRACT
    Epilepsy is a chronic brain disorder characterized by tendency to recurrent seizures or fits. The seizures can leads to loss of consciousness, disturbance of movement, muscle spasms, autonomic and mental functions. Epilepsy is developed because of imbalance in nerve signalling chemical called neurotransmitters. During epilepsy, the level of excitatory neurotransmitter glutamate increases and the level of inhibitory neurotransmitter GABA decrease. These lead to abnormal signalling in brain causes epilepsy. Primary diagnosis of epilepsy includes eye–witness and family history. Electroencephalograph (EEG) is the cornerstone for diagnosis of epilepsy and measures the brain wave activity. Neuroimaging like computed tomography (CT) scan, magnetic resonance imaging (MRI) and positron emission tomography (PET) techniques are used to diagnose abnormalities in structure and function of brain. Video recording is also useful for the monitoring of epileptic events. The most common approach of treatment is to prescribe antiepileptic drugs (AEDs). Three generations of AEDs including phenytoin, valproate, carbamazapine, lamotrigine, Oxcarbazepine, Primidone,Phenobarbitone,Gabapentin, Topiramate, Levetiracetam, Felbamate, Rufinamide, Zonisamide, Tiagabinand Vigabatrin etc. are prescribed. These AEDs have some teratogenic effects on  pragnent woman and lactating mother; need precautions. Instead of  pharmacological approaches, Non-pharmacological approaches also used for the treatment of epileptic seizures like ketogenic diet, atkins diet, yoga etc. Thr purpose of this review is to update the current knowledge on epilepsy classification, diagnostics, approaches of treatment, pathophysiology, mechanism of epileptogenesis and teratogenic effects.

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