Pharmaceutics Articles

A REVIEW ON GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS

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ABOUT AUTHORS:
Vikash Kumar Chaudhari1*, Vijay Yadav2, Praveen Kumar Verma1, Amit Kumar Singh2
1Department of Pharmaceutical Chemistry,
2Department of Pharmacognosy,
Kunwar Haribansh Singh College of Pharmacy, Jaunpur, U.P.
*vikashk464@gmail.com

ABSTRACT
Good manufacturing practices (GMP) is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP guidelines provide minimum requirements for pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

GOOD CLINICAL PRACTICE (GCP): A REVIEW

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ABOUT AUTHOR:
Bushra Shamim
Department of Pharmaceutics, Faculty of Pharmacy,
Hamdard University, New Delhi.
bushrashamim21@gmail.com

ABSTRACT
Good Clinical Practice (GCP) is an international ethical and scientific quality standard designed to conduct, performance, monitor, audit, record, analyse and report clinical trials. It protects the rights, integrity and confidentiality of trial subjects. Clinical research trails are increasingly playing a role in various medical disciplines.  GCP guidelines are used in clinical trials through out the globe with the main aim of protecting and preserving human rights. In this review article the historical background and the events that led up to the formation of these guidelines, key trial activities and principles of GCP are discussed.

USE OF THE LIQUISOLID TECHNIQUE FOR IMPROVEMENT OF THE SOLUBILITY AND DISSOLUTION OF CLOZAPINE

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ABOUT AUTHORS:
Gadhavi Aakash Vijaykumar*, Jaimin Kapadiya, Jitendra Patel, UM Upadhyay
Department of Pharmaceutics,
Sigma Institute of Pharmacy, Vadodara, Gujarat, India
*aakashgadhaviaks3377@gmail.com

ABSTRACT
The aim of the present work was to enhancement of Solubility and Dissolution of Clozapine using liquisolid technique. This work aimed to study the effect of different liquid vehicles on release characteristics of Clozapine. For liquisolid technique, different amount of liquid and ratio of carrier to coating material were employed. Avicel PH 102 and Aerosil 200 were used as carrier and coating material respectively and sodium starch glycolate (5%) was used as superdisintegrant. The empirical method as introduced by Spireas and Bolton 1999 was applied strictly to calculate amount of carrier and coating materials required to prepare liquisolid tablet. Quality control test like uniformity of tablet weight, uniformity of drug content, hardness, friability test, disintegration test and in-vitro dissolution tests were performed to evaluate the each batch of prepared tablets. In vitro drug dissolution profile of the liquisolid formulation were studied and compared with the Directly Compressed tablet of Clozapine in 0.1N HCL. Stability study was carried out to evaluate the stability of the tablet under humid condition. It was found to be that the optimized liquisolid tablet has high dissolution efficiency (80.44%) and lower mean dissolution time (MDT).From present study it can be concluded that liquisolid technique shows better improvement in solubility and dissolution of Clozapine than the pure drug.

A REVIEW ON IMMEDIATE RELEASE DRUG DELIVERY SYSTEMS

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ABOUT AUTHORS:
Mohalkar Rahul1*, Poul Bhagwat2, Patil S.S1, Shetkar M.A1, Dilip Chavan1
1 Department of Quality Assurance, Maharashtra College of Pharmacy, Nilanga
2 Principal of Maharashtra College of Pharmacy, Nilanga,
Latur, Maharashtra, India.
*rahulmohalkar@gmail.com

ABSTRACT:
The oral drug delivery system which includes the solid dosages form such as conventional dosages form and immediate release dosages form. Form last several decades conventional dosage forms like capsule, solid, pills, powder, solution, emulsion, suspension aerosols are used in the various treatments of acute or chronic disease. Today this formulation can be considered as primary pharmaceutical product are mostly seen in overalls market. Tablet is most popular among the all dosages forms today and recently found mostly accepted tablet dosages forms. Because of its convenience easy to administration, convenience of self administration, compactness and easy for the manufacturing. In number of cases immediate onset of action is required than conventional therapy. The basic approach used in development immediate release solid dosages form by using superdisintegrant like sodium starch glycolate (Primogel, Explotab), Polyvinylpyrrolidone (PVP) etc. which provides in instantaneous disintegration of tablet after administration. By using various techniques in can be formulate like wet granulation, direct compression etc. Hence its having A new dosage form allows a manufacturer to extend market exclusivity, while offering its patient population a more convenient dosage form or dosing regimen.

REVIEW ON DEVELOPMENT OF ORPHAN DRUG FOR RARE DISEASE

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ABOUT AUTHORS:
Kamshette Sharada*, Poul Bhagwat, Ghodke Amol
Department of Quality Assurance,
Maharashtra College of Pharmacy,
Nilanga, Maharashtra, India.
*sharadakamshette@gmail.com

ABSTRACT
Simply receiving a diagnosis of a rare disease often becomes a frustrating quest, since many doctors may have never before heard of or seen the disease. This is, however, a time of great progress and hope. Biopharmaceutical research is entering an exciting new era with a growing understanding of the human genome. Scientific advances have given researchers new tools to explore rare diseases, which are often more complex than common diseases.
“Who else has this rare disease? How many of us are there? What can I expect now? What is known or not known about this disease?” These are among the questions that patients and family members ask as they become, out of necessity, advocates for themselves or others.

ORAL CONTROLLED RELEASE DRUG DELIVERY SYSTEM- A REVIEW

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ABOUT AUTHORS:
Manisha Gahlyan*, Saroj Jain
Hindu college of pharmacy
Near Panchayat Bhawan, Gohana Road, Sonepat, Haryana
manishagahlyan@gmail.com

ABSTRACT:
Oral route has been the most popular and successfully route for controlled delivery of drugs because of the flexibility in the designing of dosage form than other routes. The immidiate release conventional dosage form lack in the efficiency of controlling the proper plasma drug concentration. This factor as well as factors such as repetitive dosing ++and unpredictable absorption leads to the concept of oral controlled release drug delivery systems. A desirable characteristic of controlled release delivery system is that the duration of drug action should be dictated by the design property of drug molecules. There are different mechanistic aspects for design of oral controlled release drug delivery systems such as matrix, reservoir, osmotic pressure, ion exchange resins, altered density etc. This article contains brief review on currently existing oral controlled system and various formulation approaches for the controlled release system.

A REVIEW ON STABILITY GUIDELINES BY ICH AND USFDA GUIDELINES FOR NEW FORMULATION AND DOSAGE FORM

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ABOUT AUTHORS:
Anilkumar S. Chinchole1*, B.N.Poul2, C.V. Panchal1, D.V. Chavan1
1Department of Quality Assurance, Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India
2Principal of Maharashtra College of Pharmacy, Nilanga
Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India
*anilc14@gmail.com

ABSTRACT
Stability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this article. Stability testing Provide a evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. To establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Because physical, chemical or microbiological changes might impact the efficiency and security of the final product. To minimize the Adverse Effects Of Instability In Drug Products Loss of potency of drug such as Change in concentration of active drug, Alteration of bioavailability, Loss of content uniformity, Loss of pharmaceutical elegance and patient acceptability, Formation of toxic degradation products.

FORMULATION AND EVALUATION OF SUSTAIN RELEASE TABLETS OF RAMIPRIL

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ABOUT AUTHORS:
B.Venkateswara Reddy*, K.Navaneetha
Department of Pharmaceutics, St. Pauls College of Pharmacy,
Turkayamjal, Hayathnagar, R.R. Dist., Andhra Pradesh.
*basu.pharmacist@gmail.com

ABSTRACT:
Objective:
Sustained release tablets of ramipril were prepared in order to increase the half life (3 hours) of the drug and to reduce the adverse events associated with ramipril, a drug used in treatment of hypertension.
Methods:
The tablets were prepared by direct compression method and evaluated for various parameters. HPMC K15, HPMC E15 and HPMC K4 were used as sustain release polymers.
Results:
IR spectroscopic studies indicating that the drug is compatible with all the excipients and there was no drug-polymer interaction. The results of preformulation studies indicate that the powder blend has good flow properties. Tablets prepared by direct compression method are evaluated for thickness, hardness test, friability test, uniformity of weight, drug content estimation. All the formulation were found to be good appearance without showing any chipping, capping and sticking defects and all parameters were also passed the test.
Conclusion:
When comparing all formulation, F1containing HPMC K15 showed a sustained release of 98.7% at end of 16th hour. Percentage drug release obtained from sustained release tablets of ramipril were subjected for kinetic treatment for kinetic treatment to know the release order and was found that F1 formulation follow zero order release and follow the mechanism of both diffusion and erosion.

CYCLODEXTRINS AND THEIR PHARMACEUTICAL APPLICATIONS

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ABOUT AUTHORS:
*Abdulrhman. A. Akasha,  Malak Ali Elwahedi,  Areej Mohmoud Eldeeb
Department of Pharmaceutics, Faculty of Pharmacy,
Tripoli University, Libya.
*akashaabdu@yahoo.co.uk

ABSTRACT
Cyclodextrins are formed by the action of cyclodextrin-trans-glycosidase enzyme (CTG) on the medium containing starch. Cyclodextrins are cyclic oligosaccharides containing at least six D-(+)- glucopyranose units attached by α (1-4) glucoside bonds. The three natural cyclodextrins, α , β and γ differ in their ring size and solubility.
One of the striking feature of cyclodextrins is their ability to form inclusion complexes with a variety of compounds, by entrapping their molecules (guest) inside the cyclodextrin cavity, which act as a host. Cyclodextrin complexing agent are often used, in pharmaceutical formulation of oral products, to increase the bioavailability of poorly water soluble or unstable drug. The simplified review presents the evaluation of cyclodextrins drug complexes in pharmaceutical formulation. The preparation of sodium valproate phenytoin sodium/ β-cyclodextrin inclusion complex in a trial to stabilize the drug against moisture absorption and forming non-hygroscopic powders which are suitable for tablets by direct compression was reviewed. The preparation of phenytoin sodium / β-cyclodextrin inclusion complex in a trial to stabilize the drug against moisture absorption and mask its bitter taste was reviewed.
The preparation of piroxicam/ β-cyclodextrin inclusion complexes is a exhibited higher dissolution rates and absorption efficiency values, than the corresponding un-complexes drug.
Cyclodextrins as complexing agents are often used in pharmaceutical formulation of oral products to increase the bioavailability of poorly water soluble or unstable drugs.

INVESTIGATION OF HYDROGEL THICKENED MICROEMULSION FOR TOPICAL ADMINISTRATION OF MELOXICAM

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ABOUT AUTHORS:
Tulsi. P. Upadhyay*, Jitendra Patel, Harsh. A. Vyas, Nirali. N. Thakkar, Kruti. C. Patel, Umesh. M. Upadhyay

Department of Pharmaceutics,
Sigma Institute of Pharmacy,
Vadodara, Gujarat, India
*tulsiupadhyay90@gmail.com

ABSTRACT:
The present study was conducted to investigate the microemulsion based gel of meloxicam in order to bypass gastrointestinal side effects with more patient compliance. Microemulsion existence range was defined by pseudo ternary phase diagram. Pseudoternary phase diagrams were developed for combination of Iso propyl Myristate (oily phase), Tween80:PEG400 (surfactant : cosurfactant) and water (aqueous phase) with Aqueous phase titration method. Various microemulsion formulations were prepared and further evaluated for various parameters like pH, conductance, transmittance, drug release, etc.Optimized formulation of Microemulsion was thickened with gelling agent Carbopol 940 to yield a gel with desirable properties facilitating the topical application. Safety of formulation was evaluated using skin irritancy test. Simple Meloxicam gel and optimized microemulsion gel then subjected to in vitro drug release comparison study. Drug exhibited maximum solubility in Iso propyl Myristate as oily phase among all selected oils and maximum solubility in Tween80 and Polyethylene Glycol 400(PEG400) as surfactant and cosurfactant. The pseudoternary phase diagram has been delineated at surfactant : cosurfactant ratio 2:1. Microemulsion showed -0.5 zeta potential which is desirable for its stability and average particle size was obtained less than 200nm. Microemulsion based gel afford better drug release when compared to simple gel. Present work concluded that microemulsion based gel can be promising formulation for application of Meloxicam with good patient compliance too in treatment of rheumatoid arthritis, osteo arthritis and ankylosing spondylitis.

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