Pharmaceutics Articles

A REVIEW ON INTERNATIONAL REGULATORY CONCERN ON ROLE AND RESPONSIBILITY OF PHARMACEUTICAL HIGHER MANAGEMENT

ABOUT AUHTORS
Suleman S. khoja * 1, Sohil S. khoja 1, Karim R. Panjwani1,
Jagdish Ray 1 , Parthkumar H. chauhan 2

1 Resource person in Pharmaceutical Quality Assurance,
Audit and Compliance, Vapi .
2 Resource person in Quality Assurance,
Navsari
*premukhoja@gmail.com

ABSTRACT:
It has been always International Regulatory concern on Role and Responsibility of Pharmaceutical Higher Management in  this review article we have taken some of the concern and how responsible  leadership should ensure the support and commitment of staff at all levels and sites within the organization to the Pharmaceutical Quality System ,management review , Quality committee and to make a platform for leadership engagement, awareness and decision making around quality and process performance. Implement new controls as per GMP Guidelines to check impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry.


SIGNIFICANCE OF PHARMACEUTICAL REGULATORY BODIES - A REVIEW

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ABOUT AUHTORS
G. TARUN KUMAR REDDY *1, G. NAVEEN KUMAR REDDY 2
1 Department of Pharmaceutics and Drug regulatory affairs,
Annamacharya college of Pharmacy,
Rajampet, Kadapa, Andhra Pradesh, India.
2 Department of Pharmaceutical analysis,
Sri Padmavathi school of Pharmacy,
Chittoor, Andhra Pradesh, India.

*gtarunkreddy@gmail.com

ABSTRACT: 
The regulatory bodies are being established in various pharmaceutical industries across the globe which plays a vital role to meet the requirements of legal procedures related to drug development process in a country. The pharmaceutical industry is considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Countries possess their own regulatory authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of pharmaceutical products. In an ever-changing regulatory environment, the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug. This article describes about the development of the drugs as it is a cumbersome process which includes several months of time, volunteers, and a huge finical investment majorly through the funding process, so it is strictly regulated as per the norms and regulations as given by those individual countries to carry out the drug development which were generally governed by the Drug Regulatory Affairs Personals.


SUSTAINED RELEASE EFFERVESCENT FLOATING BILAYER TABLETS A REVIEW OF NOVEL APPROACH

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ABOUT AUHTORS
*P.Dhaneshwar1, P.Stephen2, A.N.RAJALAKSHMI1
1* Department of Pharmaceutics,
College of pharmacy,
Mother Theresa Post Graduate & Research Institute Of Health Sciences, Puducherry, India
2 Sai mirra innopharm pvt ltd,
Ambattur, Chennai, India
*dhanesh7pharma@gmail.com

Drug absorption in the gastrointestinal tract is a highly variable process and prolonging gastric retention of the dosage form extends the time for drug absorption. Novel drug delivery system overcomes the physiological problems of short gastric retention through various approaches including floating drug delivery systems (FDDS), these systems float due to bulk density less than gastric fluids and so, remain buoyant in the stomach for a prolonged period of time, releases the drug slowly at the desired rate from the system and increase the bioavailability of narrow absorption window drugs. This review entitles the applications of sustained release effervescent floating bilayer tablets, suitable for sustained release of those drugs incompatible with floating constituents over an extended period of time for better patient compliance and acceptability. The purpose of this paper is to review the principle of sustained release effervescent floating drug delivery system, current technology used in the development of same as well as summarizes the applications, advantages, methodology, evaluation methods and future potential for sustained release effervescent floating bilayer tablets


NANOCAPSULES: NANO NOVEL DRUG DELIVERY SYSTEM

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ABOUT AUHTORS
Gauri Nilewar*, P.B. Mute, P.P. Talhan, Shruti Thakre,
Dr. R.G. Bhoyar college of Pharmacy,
Wardha Maharashtra, India
*samvedna.nahatkar90@gmail.com

ABSTRACT
Nano capsules are vesicular systems in which the drug is confined to a cavity consisting of an inner liquid core surrounded by a polymeric membrane. Nano capsules having various advantages and disadvantages. Preparation of Nano capsules can be used as a two types of polymers 1) Natural polymers 2) Synthetic polymers. Nano capsules are prepared by different method those are a) Solvent evaporation b) Nano precipitation c) emulsification / Solvent diffusion d) Salting out e) Dialysis f) Super critical fluid technology. Different characterization and evaluation tests are performed to Nano capsules. Dispersed polymer nanocapsules can be used as nano-sized drug carriers to get controlled release as well as efficient drug targeting. Drug-loaded polymeric nanocapsules have showed possible applications in the field of drug delivery systems. Enormous research efforts have been performed in order to develop modern nano-particulate drug delivery systems. However, newly developed drug molecules with moderate biopharmaceutical profile are still missing. The entrapment of this drug molecule can protect them from the biological environment and facilitate their transport through biological barriers. Therefore nano-carriers especially nanocapsules (NC) can give the promise for therapeutic benefits in the field of drug delivery system. Nanocapsules, existing in miniscule size, range from 10 nm to 1000 nm. They consist of a liquid/solid core in which the drug is placed into a cavity, which is surrounded by a distinctive polymer membrane made up of natural or synthetic polymers. They have attracted great interest, because of the protective coating, which are usually pyrophoric and easily oxidized and delay the release of active ingredients.


NANOPARTICLE - NOVEL DRUG DELIVERY SYSTEM: A REVIEW

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ABOUT AUHTORS
Hnawate R.M*., Deore P.
Dr. Vedprakash Patil Pharmacy College,
Aurangabad,
Maharashtra, India
ravi_hanwate@yahoo.co.in

ABSTRACT
For the past few years, there has been a considerable research on the basis of Novel drug delivery system, using particulate vesicle systems as such drug carriers for small and large molecules. Nanoparticles, Liposomes, Microspheres, Niosomes, Pronisomes, Ethosomes, Proliposomes have been used as drug carrier in vesicle drug delivery system. Nanotechnology refers to the creation and utilization of materials whose constituents exist at the nanoscale; and, by convention, be up to 100 nm in size.. Nanoparticles are being used for diverse purposes, from medical treatments, using in various branches of industry production such as solar and oxide fuel batteries for energy storage, to wide incorporation into diverse materials of everyday use such as cosmetics or clothes, optical devices, catalytic, bactericidal, electronic, sensor technology, biological labelling and treatment of some cancers. Various polymers have been used in the formation of Nanoparticles. Nanoparticles have been improving the therapeutic effect of drugs and minimize the side effects. Basically, Nanoparticles have been prepared by using various techniques as such dispersion of preformed polymers, polymerization of monomers and ionic gelation or co-acervation of hydrophilic polymer. Nanoparticles have been evaluated by using parameters of drug entrapment efficiency, particle shape, drug release study


FORMULATION AND EVALUATION OF ATOMOXETINE HYDROCHLORIDE SUSTAINED RELEASE TABLETS

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ABOUT AUHTORS
Seema Farheen1*, Shaik Zubair1 , Alwala Arpini1, Govindapuram Kalpana  Goud2,  Saidulu Soppari3, Mangulal Kethavath4
1Department  of pharmaceutics,
Vijaya College Of Pharmacy, Ranga Reddy, Telangana, India.
2Department  of pharmaceutical Analysis and Quality Assurance,
SLC’S College Of Pharmacy, Nalgonda, Telangana, India.
3Department  of pharmacology,
SLC’S College Of Pharmacy, Nalgonda, Telangana, India.
4Department  of pharmaceutics,
SLC’S College Of Pharmacy, Nalgonda, Telangana, India
*seemafarheen75@gmail.com

ABSTRACT
Atomoxetine hydrochloride (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Tablets of Atomoxetine Hydrochloride were formulated as sustained release tablet employing tamarind seed polysaccharide, guar gum, PVP, Mg. stearate, MCC  the sustained release tablets was investigated. Sustained release matrix tablets contain Atomoxetine Hydrochloride were developed using different drug polymer concentration of tamarind seed polysaccharide, guar gum,. Tablets were prepared by directly using MCC. Formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The resulting formulation produced robust tablets with optimum hardness, thickness consistent weight uniformity and low friability. All tablets but one exhibited gradual and near completion sustained release for Atomoxetine Hydrochloride, and 98.6% and 97.5 released at the end of 12 hrs. The results of dissolution studies indicated that formulation F8, the most successful of the study. An increase in release kinetics of the drug was observed on decreasing polymer concentration


A REVIEW ON QUALITY AGREEMENT REQUIREMENT IN PHARMACEUTICALS BY REGULATORY AUTHORITY IN COMPLIANCE TO CGMP GUIDELINES

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ABOUT AUHTORS
Suleman S khoja*1,Sohil S khoja1, Farhad S Khoja2,Shamim S Khoja2, Narmin A Pirani2
1 Resource person in Pharmaceutical Quality Assurance and Facility Audit,
Vapi, Gujarat, India.
2 Registered Pharmacist, Gujarat State Pharmacy Council, Gujarat, India
*premukhoja@gmail.com

ABSTRACT
A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP. Quality agreements may be reviewed during inspections. A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP. The quality agreement should explain how the contractor will report manufacturing deviations to the owner, as well as how deviations will be investigated, documented, and resolved in compliance with CGMP. Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with CGMP. The most critical pieces are quality and change control, as described in the following sections. Manufacturing Activities Change Control Associated With Manufacturing Activities


NANO-PARTICLES CONTAINING ANTICANCER DRUG

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ABOUT AUHTORS
Debpratim Chakraborty*, Nisha Lama Yolmo
Department of Pharmaceutical tech,
Jadavpur University,
Kolkata, West Bengal, India
*debpratim008@gmail.com

ABSTRACT:
Now a day in medical science and researches, cancer is one of the most life threatening disease but unfortunately still now we have no medical treatment for procurement of this disease. The pathology is not totally clear but according to medical evidence if we consider genes then we must agree that oncogene and tumor suppressor genes are mainly responsible. There are some risk factor also consider which may leads to cancer. The conventional treatments are surgery, Radio-therapy and chemo therapy but the real fact is none of the above mentioned treatment is enough for procurement of cancer and that’s why now scientist and researchers are thinking about nan-technology. NCI has identified that nano-technology have the potential to make paradigm changing impacts on the detection, treatment and prevention of cancer.  There are different strategies for cancer therapy using nano-particles like targeted and non-targeted nano-particles. Different studies show that the side effect of doxorubicine (an anticancer drug) can be minimizing by nano-technology, which also reduce the multi drug resistance. Nano-sphere and Nano-capsule of anti-steroid 4-hydroxytamoxifen RU reduce estrogen dependent tumor. Dendritic nano-technology with 5-fluro Uracil decreases the drug clearance and increase the therapeutic time. Methotrixate incorporated dendritic polymer target the folic acid receptor. Camptothecin loaded nano-particles show longer plasma retention, high and longer tumor localization. Nano-particles prepared by poly-lactic-co-glycolide increase the half life of Cisplatin. Paclitaxel, a microtubule-stabilizing agent that promotes polymerization of tubulin causing cell death by disrupting the dynamics necessary for cell division, is effective against a wide spectrum of cancers. Miscellaneous agent like Arsenic trioxide, Butyric Acid, Diethylene-triamine-Acetic acid show more prominent activity. Recent development in nanoparticle-based combination therapy have shown several unique features that are untenable in traditional chemotherapy. Drug combinations can now be optimizedand cleverly delivered in a more effective way.


SOLUBILITY ENHANCEMENT OF POORLY WATER SOLUBLE DRUG BY SPHERICAL CRYSTALLIZATION TECHNIQUE

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ABOUT AUHTOR
HardikRana*, BhargavVaghasiya, MansiDholakia
Department of Pharmaceutics,
Anand Pharmacy College, Anand, 388 001, Gujarat, India.
*hardikrana1439@gmail.com

ABSTRACT
The objective of present study was to enhance the solubility of poorly soluble drug Ibuprofen using spherical crystallization technique.The potential agglomerates were prepared by addition of different concentrationof polymer selected on the basis of Phase solubility study. Spherical agglomerates were prepared using diethyl ether as bridging liquid by neutralizing technique, spherical agglomeration technique, Quasi emulsion solvent diffusion technique. Spherical agglomerates were evaluated for morphology, production yield, drug content, particle size and dissolution behaviour compared with pure drug.The result of phase solubility studies revealed that there is enhancement of solubility by PEG 4000. Rod shaped crystals of pure drug converted to spherical was confirmed by optical microscopy. The dissolution of agglomerates of optimum batch exhibited 88.24% release compare to 47.18% of pure drug within 60 minute. This study demonstrated that spherical crystallization technique can be consider as a suitable alteration of granulation. Ibuprofen spherical agglomerates can be prepared with PEG 4000. It exhibited excellent physicochemical, solubility, dissolution rate in comparison with pure drug. Among other spherical crystallization technique, QESD proved to be excellent techniquefor enhancement of solubility and dissolution.


IN-VITRO ANTIPROLIFERATIVE ACTIVITY OF M. AZEDARACH

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 ABOUT AUHTORS
Deepak Chowrasia1*, Nisha Sharma1, Mohammad Arshad2
1 University Institute of Pharmacy,
CSJM University, Kanpur, U.P., India
2Molecular Endocrinology Lab, Department of Zoology,
Lucknow University, Lucknow, U.P., India
* chowrasia.deepak@gmail.com

ABSTRACT
Preliminary screening of different crude extract of. M. azedarach was evaluated against human cancer cell lines viz. MCF-7 (breast cancer), SaOS-2 (osteosarcoma), and A431 (epidermoid carcinoma) to search for better herbal based anticancer agent. Solvents used were water, methanol, ethanol, n-butanol, & n-hexane. It has been found that among solvents, methanolic extract of M. azedarach shows comparatively superior activity suggesting presence of phytoconstituents comprising polar functionalities.


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