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Pharmaceutics Articles


FORMULATION EVALUATION AND OPTIMIZATION OF MEBENDAZOLE COLON TARGETED SUSTAIN RELEASE PELLETS BY EXTRUSION SPHERONIZATION

ABOUT AUTHORS:
Raval Aniket*, Chauhan Sachin P., Sheth A.K, Shah Nirmal, Aundhia Chintan
Department of Pharmacy, Sumandeep Vidyapeeth University,
At & Po Pipariya, Ta. - Waghodia, Dist. Vadodara, Gujarat, India
aniket_raval2006@yahoo.co.in

ABSTRACT:
The aim of present investigation is to formulate evaluate and optimization of colon targeted pellets bearing mebendazole, benzimidazole derivative with broad spectrum of anthelminthic activity. It is highly effective against adult and larval stages of ascaris lumbricoids, hook worms and  indicated for the treatment of nematode infestation. Pellets were prepared by extrusion spheronization process using microcrystalline cellulose as spheronizing aid, natural polysaccharide pectin as binders in three different percentages i.e 5%, 10% and 15% and glycerine as plasticizer.  Further study was carried out to select the natural polysaccharide for formulation of colon targeted pellets i.e. Pectine, Xanthan gum and Guar gum. The formulation were prepared with optimized constant process parameters i.e. Percentage LOD 10%, Spheronization time 3 minutes and Speed of spheronization 700-1200 rpm. Prepared A1 – A9 batches were then evaluated by their micromeritic properties like tapped density, carr’s index,hausner,s ratio, angle of repose  and characterized by microscopic study, % yield, hardness, friability, % assay and dissolution study was carried out and compared with marketed formulation by statistical analysis similarity factor(f2). The batch A5 is having 10% pectin, 18% MCC and 20% mebendazole shows (22.20±2.05) % carr’s index, (1.22±0.04) hausner’s ratio, (26.65±1.15) angle of repose, (88.2±2.36) % yield, (3.96±0.46) hardness, (0.23±0.03) % friability  (88.47±3.26) % assay and (99.81±3.80) % drug release after 10 hours. Pellets equivalent to 300mg of mebendazole  were then filled in capsules and capsules coated with 12.5% w/v Eudragit S 100 using optimized 4- 5 ml/min spray rate, 15 rpm pan speed and 40±5°C coating inlet temperature and then optimized for % weight gain in four different trials. W2 batch having 10% weight gain were then evaluated by % cumulative drug release, disintegration test in 0.1 N HCl shows (99.73±3.34) % CDR, intact after 12 hours. The pellets of batch A5 and the enteric coated capsule with 10 % weight gain were packed in aluminum pouch and charged for accelerated stability studies at (40°C±2°C) and (75%±5%) RH for 1 month in a stability chamber shows no change in the dissolution profile at (40°C±2°C) and (75%±5%) RH storage condition.


ALTERNATIVES TO THE DRAIZE EYE TEST

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

ABSTRACT
Industry and regulatory bodies responsible for public health are actively assessing animal free tests to reduce the requirement for Draize testing. Draize rabbit eye irritation test developed in the 1940’s is even today the only eye toxicity test officially accepted in the OECD countries for regulatory purposes in the classification of slightly and moderately irritating chemicals. The Draize test has been widely criticized for both scientific and ethical reasons, and alternatives have been investigated for several decades. Therefore in an attempt to minimize this conflict alternative methods have been investigated. This article presents those alternative methods that are currently the most developed and the most widely used.


PRODUCT QUALITY COMPLAINT MANAGEMENT IN PHARMACEUTICAL INDUSTRY – AN OVERVIEW

ABOUT AUTHOR:
Himani Devliyal
Department of Pharmacology,
Delhi Institute of Pharmaceutical Sciences and Research
Delhi University, New Delhi
himanidevliyal@gmail.com

ABSTRACT
This article covers fundamental basics of product quality complaint. We would learn what product quality is all about, how the product quality complaints are made, processed, investigated and changes implemented. Also we would go through the basics of case processing, how the complaints are classified, categorized based on the priority and then investigated. We would also go through the formal process of responding to the customer and increasing their faith in the company.
A PQP (product quality problem) can be defined as an issue arising due to change in color, odor, appearance, quality, safety and effectiveness of a product. A PQP is a grave concern and is directly related to the efficacy and safety of a drug.


FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET OF SILYMARIN

ABOUT AUTHORS:
Brij Mohan*, Seema Saini, Sachin Dev Sharma, Mohit Kumar
Department of Pharmaceutics,
Rayat Institute of Pharmacy, SBS Nagar, Punjab
rana.brijmohan@gmail.com

ABSTRACT:
In this investigation mouth dissolving tablets of Silymarin were prepared using different superdisintegrants by dry granulation method. Fast dissolving tablets were evaluated for physicochemical properties and in vitro dissolution. The preformulation studies and tablet evaluation test were performed and result were within the limit. The powder blend was evaluated for angle of repose, bulk density, tapped density, compressibility index and Hausner ratio. The powder blend show satisfactory flow properties. The silymarin tablet evaluated for tablet general appearance, hardness test, weight variation and drug content estimation. Oral route is the most preferred route for administration of various drugs because it is regarded as safest most convenient and economical route. Recently researcher develop the new dosage form fast dissolving tablet (FDT) with improve patient compliance and convenience. Fast dissolving tablets which dissolve rapidly in saliva without additional water and chewing. Fast dissolving tablets overcome the disadvantages of conventional dosage form especially dysphagia in pediatric and geriatric patients.
All the formulations shows uniform weight, hardness and friability data indicates good mechanical resistance of the tablet. All the tablets were disintegrated between min. The optimized (F6) formulation showed good disintegration time and release profile with maximum drug being released.


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

ABOUT AUTHORS:
Vikash Kumar Chaudhari*, Vijay Yadav, Praveen Kumar Verma, Amit Kumar Singh
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.


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

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.


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