Pharmaceutics Articles

QUALITY BY DESIGN

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ABOUT AUTHORS:
Chaudhary Sonam*, Rathore KS
Department of Pharmaceutics,
Bhupal Noble’s Institute of Pharmaceutical Sciences,
Sewashram road, Udaipur, Rajasthan, India
*chaudharysonam1993@gmail.com

ABSTRACT
A new approach to drug development could increase efficiencies, provide regulatory relief, flexibility, and offer important business benefits throughout the product’s life cycle. Quality by design is a systemic approach and essential part of the modern approach for quality and pharmaceutical development.

It includes defining target product quality profile, designing product, developing formulations, manufacturing processes, identifying critical quality attributes,  process parameters, sources of variability and controlling manufacturing processes to ensure consistent  product quality over time.

Pharmaceutical quality can be assured by understanding, controlling formulation and manufacturing variables using Quality by design. Product quality can be confirmed by product testing. Pharmaceutical industry have to  work hard to develop, manufacture, to bring  new drugs to market, to comply with regulatory requirements to ensure  that the drugs are safe and effective. Implementation of Quality by design leads to transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.


FORMULATION DEVELOPMENT AND EVALUATION OF DELAYED RELEASE ENTERIC COATED PARACETAMOL TABLETS

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ABOUT AUTHORS:
Vivek P. Chavda*, Moinuddin M. Soniwala
Department of Pharmaceutics,
B.K. Mody Government Pharmacy College, (Affiliated to Gujarat Technological University)
Rajkot – 360003, Gujarat (India)
*vivek7chavda@gmail.com

ABSTRACT:
The aim of this study was to investigate and evaluation of delayed release enteric coated paracetamol tablets. Successful delivery of drugs specifically to the intestine requires the protection of drug from being released in stomach. PCM core tablets were prepared with and without superdisintigrant using wet granulation method. Dip coating method is used for coating were different concentration of Eudragit L100 is used as coating agent. Preformulation studies like angle of repose, bulk density, tapped density, porosity, Carr's index, Hausner's ratio were performed. The FDT2 batch shows the highest drug release at end of total 135 min of 94.13 % which are the satisfactorily promising results. So, we can conclude that the FDT2 is the optimized batch among all three batches. From the reproducible results obtained from the executed experiments it can be concluded that Eudragit L 100 can be used as enteric coated polymer. These results reflect that PCM can be successfully enteric coated in order to prevent its release in the stomach and facilitate rapid release of the drug in the duodenum, due to the presence of superdisintegrant. Formulating these enteric coated tablets could increase patient compliance by decreasing adverse drug reactions (ADRS) associated with PCM therapy.


FORMULATION DEVELOPMENT AND IN-VITRO EVALUATION OF FLOATING TABLETS OF CEFIXIME

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ABOUT AUTHORS:
B.Venkateswara Reddy
Department of Pharmaceutics,
St.Pauls College of Pharmacy, Turkayamjal (V),
Hayathnagar (M), R.R.Dist-501510, India.
basu.pharmacist@gmail.com

ABSTRACT:
Objective:
Cefixime is a third generation cephalosporin antibiotic having bactericidal activity by inhibition of cell wall synthesis and is used in the treatment of uncomplicated UTI, pharyngitis and tonsillitis, acute bronchitis and acute exacerbation of chronic bronchitis, uncomplicated gonorrhoea etc. The concept of formulating floating tablets containing Cefixime offers a suitable and practical approach in serving desired objective of retaining the drug in the stomach to increase the its bioavailability.
Methods:
The tablets were prepared by direct compression methodand total of 12 formulations are developedemploying HPMC K100M and HPMC K15M as polymers for sustaining the drug release and sodium bicarbonate as the gas generating agent.
Results:
Various polymers have been selected and subjected to IR-spectroscopic studies and found that there were no drug–excipient interactions. The powder blends of all the formulations have shown good flow properties. Other parameters such as hardness, friability, drug content uniformity, Floating lag time and in-vitro dissolution studies were performed and the results were satisfactory.
Conclusion:
Formulation F 12 was found to be best in all aspects and was considered as optimized formulation, it has a low floating lag time of  2mins  and has shown a maximum drug release of 99% at the end of 24 hours and drug release was by diffusion through the polymer matrix.


TAILOR-MADE MEDICINE: A STEP TOWARDS FUTURE OF DIAGNOSTICS AND THERAPEUTICS

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ABOUT AUTHORS
Vivek P. Chavda
Department of Pharmaceutics,
B.K. Mody Government Pharmacy College, Near Aji dem, Rajkot-Bhavnagar highway,
Gujarat technological university, Rajkot-360003, Gujarat (India)
vivek7chavda@gmail.com

ABSTRACT
The goal of tailor-made medicineis to maximize the likelihood of therapeutic efficacy and to minimize the risk of drug toxicity for an individual patient. It involves right drug & dose, right patient and at right time administration of a medication. By averting the knowledge of gene sequence and their functions, biomedical research are diversified towards inter-individual variations that are expected to become an eminent part of treatment planning in terms of efficacy and toxic side effects of drugs. tailor-made medicinefocuses on individualized drug treatment according to each patient’s molecular diagnosis and genetic makeup. Genomic-based diagnostics can play a key role in creating a more efficient healthcare system by directing patients toward beneficial therapies and away from therapies that pose substantial risk or are unlikely to improve outcomes for the patient.


FORMULATION AND PRODUCT DEVLOPMENT OF PRESSURISED METERED DOSE INHALER: AN OVERVIEW

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ABOUT AUTHORS:
*S R Thorat1, S M Meshram2
1Lupin Research Park, Hinjewadi, Pune, Maharashtra
2TATA Consultancy Services, Hinjewadi, Pune, Maharashtra
santoshthorat345@gmail.com

ABSTRACT
Pressurized metered dose inhalers (MDIs) are widely used dosage form for treatment of respiratory diseases, such as asthma and chronic obstructive pulmonary disease. The metered dose inhaler (MDI) contains the active pharmaceutical ingredient dispersed or solubilised in a high vapour pressure propellant and metered accurately in tens to hundreds of micrograms and administered directly to the lungs. The most dominant characteristics of MDI include their portability, convenience of use and quick effect. MDI comprises of drug formulation, propellant, metering valve, actuator, and container. This review contains overview of excipient selection, primary packaging material, propellant selection and formulation development of pMDI. Two of the most commonly used methods for the manufacturings of MDIs are cold filling method and pressure filling method.This review demonstrates different analytical techniques for characterization of pMDI’s like uniformity of delivered dose, water content, spray pattern and plume geometry were discussed. This review also presents in-vitro characterization, pharmacokinetic and pharamcodynamic study of MDI.


BIONANOPARTICLES: A GREEN NANOCHEMICAL APPROACH

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ABOUT AUTHORS:
Rahul Kumar*, Ved Prakash Singh, Damini Maurya, Anand Kumar Pandey
Department of Biotechnology, Institute of Engineering and Technology
Bundelkhand University, Jhansi, Uttar Pradesh, India
vnsanand_9@rediffmail.com

ABSTRACT
Nanoparticle, a core of bio-nanoparticle, which is used for polymers including natural and synthetic polymer and form different types of, liposomal and polymer nanoparticle. The designing, synthesis and manipulation of structures which is smaller than 100 nm, is termed as Nanotechnology. Nanoparticles are developed as a colloidal structure, synthesized by semi-synthetic and synthetic polymers. The emerging area of nanotechnology and Nano-sciencesare the application of nanoparticles, ranges in 1 to 100 nanometre (nm). The synthesis of silver nanoparticles for their potential application, it was originate to be eco-friendly and reliable, because of their exclusive properties. Mostly synthesis of AgNPs, by physical and chemical methods are too expensive, toxic, hazardous chemicals for various biological risks.The main objective of this study preferably lies thatgreen synthesis of AgNPs by several plants and its metabolites, extracts can be much safer to handle and easily available. The synthesis of AgNPs  are using several plants extract such as Oryza sativa, Zea mays, Basella alba, Helianthusannuls, Camellia sinensis ( green tea), Azadirachta indica (neem) ,Ssebania drummondii (leguminous shrub)sp. The AgNPs get attached in the cell wall of microorganism and can disturb the cellular respiration, permeability of the cell wall. Sometimes it can penetrate inside the cell wall which can interact protein, DNA, sulphur and phosphorus and causing cellular injury inside cell. It confers the antimicrobial activity. The AgNPs shows less antimicrobial activity against gram positive bacteria in comparison to gram negative bacteria because gram negative contain β-barrel proteins (i.e. Porins) and thinner peptidoglycan. The distinguishing property of silver nanoparticles it can be have higher surface area to volume ratio. When surface area increases the catalytic activity and surface energy of AgNPs corresponding to increase and biological effectiveness also increases. 

It identified that amalgamation of silver nanoparticle biochemical process is very fast process as compare to using microorganism (even several hours to few days). The NPs monodispersity, size are significant part in the valuation of NPs amalgamation. Therefore, operative regulator of monodispersity and NPs size are essentially examined. On numerous readings silver nanoparticle synthesis by microbes can be decompose later withassured dated of time. Thus the constancyof nanoparticle producebiological approachesmerits supplementary learning.


MEDICAL USES OF RADIOPHARMACEUTICALS

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ABOUT AUTHORS:
Mohammad Akbar Dar, Mubashir Hussain Masoodi*, Saeema Farooq
Dept. of Pharmaceutical Sciences,
Faculty of Applied Sciences, University of Kashmir, Srinagar, J&K, India
akbardr297@gmail.com

ABSTRACT
A radiopharmaceutical is a preparation intended for in-vivo use that contains a radionuclide in the form of a simple salt or a complex.  It may exist as a solid, liquid, gas or a pseudo gas. The chemical and physical identity and a form of a radiopharmaceutical are very important because in each case, once administered the radiopharmaceutical is intended to target certain tissues, binding sites, biochemical pathways. A radiopharmaceutical can be used for either diagnostic or therapeutic purposes depending on its specific physicochemical and radiation properties. The characteristic of radioactive decay is what makes radioisotopes useful in their medical applications; however, different applications will take advantage of radioactive emissions in different ways. Radioactive materials are regularly used to treat medical conditions, diagnosis pathology, visualize and measure physiological functions, and localize structures and pathways. This review describes both the therapeutic as well as diagnostic uses of radiopharmaceuticals.


A REVIEW ARTICLE: PRONIOSOMES

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ABOUT AUTHORS:
Shweta Vashist*, Jyoti Kaushik, Batra K. Sunil
Department of Pharmaceutics,
Hindu College of Pharmacy, Sonipat
shwetavashist55@gmail.com

ABSTRACT:
Skin is the main target of topical and transdermal preparations. Major aim of transdermal drug delivery sytem is to cross the stratum corneum. Now-a-days we better know vesicles have importance in cellular communication. Niosomal carrier are systems containing soft vesicles, composed of non –ionic surfactant and an alternative to liposomes. They can entrap both hydrophilic and hydrophobic chemicals but these types of vesicles include the superior physical stability problems such as aggregation, fusion, and leakage of encapsulated drug. Proniosomes are provesicular approach which overcomes the limitations of vesicular system (Niosomes). Provesicular approach has been proposed to enhance the stability of vesicles. Proniosomes is a compact semi-solid liquid crystalline product of non- ionic surfactant  easily formed on dissolving the surfactant in minimal amount of acceptable solvent and the least amount of aqueous phase. Proniosomes can be converted into niosomes in –situ by absorbing water from the skin.


ENHANCEMENT OF SOLUBILITY AND DISSOLUTION RATE OF SIMVASTATIN BY TERNARY SOLID DISPERSION TECHNIQUE

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ABOUT AUTHORS:
Shete Reshma S.1*, Gadhave Manoj V.2, Gaikwad D. D.3
1Department of Quality Assurance Techniques,
2Department of Pharmaceutics,
3Department of Pharmaceutics,
VJSM’S Vishal institute of pharmaceutical education and research, Ale, Pune, Maharashtra, 412411
*reshma.s.shete@gmail.com

ABSTRCT
Simvastatin is a poorly soluble drug exhibiting poor dissolution pattern. Simvastatin, PEG 6000 & Poloxamer 407 solid dispersions were prepared with a view to study the influence of polymer on solubility and dissolution of this poorly soluble drug Simvastatin. Solid dispersions of Simvastatin were prepared using different ratios of PEG 6000 & Poloxamer 407 as carrier by, solvent evaporation method. They were evaluated for percentage yield, drug content, FTIR spectral studies, DSC, XRD, solubility, and in-vitro dissolution. The solubility profile indicated that there is increase in solubility of Simvastatin when polymer concentration is increased. The solid dispersion complex of drug (1:5:5 ratios) was giving better dissolution profile as compared to pure drug and other solid dispersions. This in turn can improve the bioavailability. FT-IR, DSC shows the compatibility of drug and carrier.


DISSOLUTION METHOD DEVOLOPMENT OF FLUCONAZOLE IN FLUCONAZOLE TABLETS DOSSAGE FORM

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ABOUT AUTHORS:
Auti Snehal D.*1, Jadhav S. L2, Gadhave Manoj V3
1Department of Quality Assurance Techniques
2,3Department of Pharmaceutics
VJSM’S Vishal institute of pharmaceutical education and research, Ale, Pune, Maharashtra, 412411
snehal.d.auti@gmail.com

ABSTRACT:
The present research work discusses the development of a dissolution method for Fluconazole using UV spectrophotometer. Simple, accurate and cost efficient dissolution method has been developed for the estimation of Fluconazole in bulk and tablet dosage form. The optimum conditions for the dissolution of the drug were established. The dissolution media was found to be 0.1N HCl (pH 1.2). The apparatus was found to be USP II, Paddle and the speed was found to be 50 rpm for 30 minutes time interval.


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