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Pharmaceutics Articles

  • Pharmaceutical Process Validation: Emplication of New FDA Guidelines

    About Author:
    Ashutosh Gupta
    B.Pharm, kanpur university
    22ashutoshgupta22@gmail.com

    Abstract
    This summary represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.

  • FORMULATION  AND EVALUATION  OF CLARITHROMYCIN IMMEDIATE RELEASE FILM COATED TABLETS
    FORMULATION AND EVALUATION OF CLARITHROMYCIN IMMEDIATE RELEASE FILM COATED TABLETS

    About Authors:
    S. H. Seyed Mohamed Buhary*, Kamarapu Nagaraju, A. Thanga Thirupathi.
    Department of Pharmaceutics, Sankaralingam Bhuvaneswari College of Pharmacy,
    Sivakasi, Tamil Nadu, India.
    * nagarajukamarapu8@gmail.com

    ABSTRACT:
    The main goal of this study was to develop a stable formulation of antibiotic drug clarithromycin as an immediate-release tablet. The task of developing immediate release tablet is accomplished by using a suitable diluents and super-disintegrants. Faster disintegration of the tablet administrated orally minimizes absorption time and improves its bioavailability in less time.   The formulation development work was initiated with wet granulation. Microcrystalline cellulose PH 102 were used as diluent. Povidone was used as the binder. Croscarmellose sodium and pre gelatinized starchwas added as a disintegrating agent. Talc and magnesium stearate was used as the lubricant. The prepared granules were compressed into a compression machine.  To evaluate the formulated tablets as per requirements of standards. The tablets thus formulated showed  a satisfactory physical parameters, and it was found to be stable.Evalution Parameters Like weight variation, hardness of the tablet, friability, thickness, disintegration test, drug content uniformity and in vitro release studies were performed.To optimize the trial batch by    32 full factorial design study and determined  the best batch by in vitro release studies are showed that  optimization formulation (OF7) was 101.62% respectively. The  optimized formulation is further selected and compared with the release profile of the innovator product. The results suggest the feasibility of developing immediate  tablets consisting of clarithromycin for the convenience of patients with respiratory infections, gonorrhea, community-acquired pneumonia, pelvic inflammatory disease, pediatric otitis media and pharyngitis and Mycobacterium avium complex (MAC) in patients with advanced HIV disease.

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  • FORMULATION, EVALUATION AND OPTIMIZATION OF CLOTRIMAZOLE SOLID DISPERSION INCORPORATED GELS
    FORMULATION, EVALUATION AND OPTIMIZATION OF CLOTRIMAZOLE SOLID DISPERSION INCORPORATED GELS

    About Authors:
    Saritha. A. Surendran*, Prof.O.G. Vinaya, Santhosh. R. Iyer, Anisha. N.A
    Calicut University, College Of Pharmaceutical Sciences,
    Govt. Medical College, Calicut,
    Kerala, India
    *sarithaasurendran@gmail.com

    ABSTRACT
    The Goal of the present investigation was to design and evaluate gels for topical delivery of water insoluble antifungal agent, Clotrimazole with an aim to increase its penetration through skin. Clotrimazole is a broad spectrum imidazole derivative useful in the treatment of superficial fungal infections. Purpose was to improve the solubility, invitro characteristics and dissolution properties of Clotrimazole by the preparation of its solid dispersion with beta cyclodextrin using kneading method by using different drug carrier ratios. Prepared solid dispersion was evaluated for percent practical yield, drug content uniformity, in vitro dissolution rate, DSC and IR studies. Solid dispersions was optimized based on the release characteristics, and were incorporated into gels. Faster dissolution was exhibited by solid dispersion containing l: l ratio of drug: β-cyclodextrin by kneading method. Gels have gained more importance because the gel-bases formulations are better percutaneously absorbed than creams and ointment bases. The gels were formulated by using Carbopol 940, HPMC, and Methyl cellulose and evaluated for pH, drug content, spreadability, extrudability, viscosity determination and diffusion study. Invitro drug release of clotrimazole solid dispersion incorporated gels was showed that Carbopol gels was showed higher drug release as compared to HPMC, methyl cellulose gels.  Optimized gel was then undergone skin irritation test, stability studies, and invitro antifungal test. In conclusion, the optimized gel showed good physicochemical properties, better drug release, and reasonable stability

  • PREPARATION AND EVALUATION OF BUCCOADHESIVE BILAYER TABLETS OF ROPINIROLE HYDROCHLORIDE
    PREPARATION AND EVALUATION OF BUCCOADHESIVE BILAYER TABLETS OF ROPINIROLE HYDROCHLORIDE

    About Authors:
    M.Sateesh Kumar, C.Aparna*, Nalini Shastri, M.Sadanandam.    
    Department of Pharmaceutics, Sri Venkateshwara College of pharmacy,
    Madhapur, Hyderabad-500081, India.
    *sateeshmkt@gmail.com

    Abstract:
    Ropinirole hydrochloride buccoadhesive bilayered tablets containing bioadhesive layer and drug free backing layer were formulated to release the drug for extended periods of time with reduction in dosing frequency. The tablets were prepared by direct compression method using bioadhesive polymers like Carbopol934P, Methocel K4M, Methocel K15M, Sodium carboxy methyl cellulose, PVP K-30, Sodium alginate and Hydroxy propyl cellulose alone or in combination, Ethylcellulose has incorporated as an impermeable backing layer. Tablets were evaluated for  weight and content uniformity, thickness, hardness, surface pH, swelling index, exvivo mucoadhesion time, invitro drug release and invitro drug permeation. The modifiedinvitro assembly was used to determine and compare the bioadhesive strength of tablets with fresh porcine buccal mucosa as a model tissue All characteristics of formulated tablets were shown to be dependant on composition of bioadhesive materials used. Maximum bioadhesion strength was observed for tablets formulated with Carbopol 934P. Carbopol 934P and Methocel K4M in the ratio of 1:1 could be used to design effective and stable buccoadhesive tablets of ropinirole hydrochloride.

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  • FORMULATION AND EVALUATION OF TASTE MASKED ORODISPERSIBLE TABLETS BY ION – EXCHANGE RESINS
    FORMULATION AND EVALUATION OF TASTE MASKED ORODISPERSIBLE TABLETS BY ION – EXCHANGE RESINS

    About author:
    Ashish Vishwakarma
    Department of Pharmaceutics,
    Chandigarh College of Pharmacy,
    Mohali-140307
    ashish1931@gmail.com

    ABSTRACT-
    Acceptability of any drug dosage form mainly depends upon its taste i.e. mouth feel. In the formulation of   oro-dispersible tablet of bitter drug, the main challenge is to mask the bitter taste of drug, because the drug is dispersed and released in mouth. This is more essential in the formulation for pediatric and geriatric, bed ribbon and non-cooperative patients. There are many methods of taste masking but the main objective of this article is to explore method, technology and evaluation to mask taste of bitter drug by ion-exchange resins. Here we will study the formulation and evaluation of various oro-dispersible tablets of bitter drug. This is more economical, easiest and efficient method for taste masking.

  • Polyanhydride Microspheres for Controlled drug delivery to the Lung
    Polyanhydride Microspheres for Controlled drug delivery to the Lung

    About Authors:
    Abdulrhman A. Akasha
    Department of Pharmaceutics, Faculty of Pharmacy,
    Tripoli University, Libya-13645
    akashaabdu@yahoo.co.uk

    Abstract
    Bioerodible microspheres may provide a vehicle for achieving good aerosolisation characteristics, whilst offering a slow release depot from the pulmonary deposited fraction.  Polysebasic anhydride (PSA) was synthesised by a melt-polycondensation process using nitrogen gas under high vacuum. The products were characterised by 1H-NMR (2 & 20 KDa) and DSC (melting point: 68 & 83 °C), and with a yield (81 & 89 %) of prepolymer and polymer respectively. The polyanhydride was converted into microspheres using an oil in oil emulsification procedure.  The polymer was dissolved in dichloromethane and using 1 to 5% Span 85 or oleic acid as stabilizer, dispersed into silicone oil. The dichloromethane was removed by evaporation, the microspheres recovered and washed with petroleum ether. Laser diffraction analysis of the microspheres indicated a mean microspheres size <5 mm.  The presence of rough non-porous spheres was demonstrated by SEM.  Initial in vitro experiments were undertaken to examine the degradation rate in 0.1 M phosphate buffer at 37 °C, pH 7.4.  The process was followed for 24 hr, by which time 73% of the microsphere mass had eroded. However release of salbutamol base occurred more rapidly with 95% lost within 6-10 hr. The fact that 74% was released in the first 10 min suggest a high fraction of surface adsorbed drug. Microcarrier systems for slow release may provide a vehicle for achieving good aerosolisation characteristics, whilst offering a slow release depot from the pulmonary deposited fraction. The produced rough and non-porous microspheres containing salbutamol base were subjected for Deposition process using Andersen Mark II Cascade Impactor. The Deposition was assessed from both a Spinhaler and Rotahaler after 5s activation at a flow rate of 28.3L/min.  This resulted in an average of 33.5% (Rotahaler and 17.5% (Spinhaler) of the dose found between stages 2 and the filter corresponding to microspheres in the size range 4.7 to 0.4 mm.

  • FORMULATION AND EVALUATION OF GASTRORETENTIVE FLOATING DRUG DELIVERY SYSTEM OF PIOGLITAZONE HYDROCHLORIDE
    FORMULATION AND EVALUATION OF GASTRORETENTIVE FLOATING DRUG DELIVERY SYSTEM OF PIOGLITAZONE HYDROCHLORIDE

    About Authors:
    *Thoriya J. G, Patel S. D, Tank H. M
    Matushree V. B. Manvar College of Pharmacy- Dumiyani,
    Rajkot
    *thoriya.jignesh@gmail.com

    ABSTRACT
    Pioglitazone HCl is used for the management of type-2 diabetes. It is an absorption window limited drug, whose solubility decreases with increase in the pH and has a short half life of 3-7 h. Here an attempt is made to developed the floating matrix tablets, which design in way that after oral administration the GI resistant time is  prolonged and thus to give sustained action with increase in the bioavailability of the drug. Pioglitazone HCl showed maximum absorption at wavelength 269 nm in 0.1N HCl. various formulations were developed by using release rate controlling and gel forming polymers like HPMC, and Carbopol-934 in single and combinations by direct compression method with the incorporation of sodium bicarbonate as gas generating agent. The prepared tablets were characteristics by drug content, floating property, swelling and in vitro dissolution test using USP dissolution test apparatus Type – II (paddle method) in dissolution medium of 0.1 N HCl. The in vitro dissolution results of all tablets were computed by using dissolution software. The prepared tablets were found to be good hardness, diameter, weight variation, thickness, friability drug content, floating property and in vitro drug release. Drug-polymer compatibility studies by FTIR gave conformation about drug purity and showed no interaction between drug and selected polymers. All the formulations had floating lag time below 3 minutes and constantly floated on dissolution medium for more than 12 h. Swelling studies indicated significant water uptake and contributed in drug release. From among all the developed formulations, as F7 prolonged the drug release (95.45 %) for longer period of time (12 hrs.); they were selected as best formulations. The best formulations were found to be stable during stability studies for two months. Thus, selected formulations satisfied floating time, swelling index and in vitro drug release profile requirements for a floating drug delivery system.Tablets of Pioglitazone HCl prepared with HPMC K4M, HPMC K100M and Carbopol 934P were found to be acceptable floating property, water uptake and in vitro drug release.

  • RECENT ADVANCEMENTS: MICROSPONGE DRUG DELIVERY SYSTEM; A REVIEW
    RECENT ADVANCEMENTS: MICROSPONGE DRUG DELIVERY SYSTEM; A REVIEW

    About Authors:
    Deepak Sharma*, Arunabha Banik, S k Gupta
    Department of Pharmaceutical Technology,
    MIET,Meerut
    *thakraan.southcarolina@gmail.com

    ABSTRACT
    The Microspongesdelivery system are extremely small, inert,indestructibleclusters of even tinierspherical particles of microscopic sizepatented polymeric delivery systems consisting of porous microspheres that can entrap a wide range of active ingredients such as emollients, fragrances, essential oils, sunscreens, and anti-infective, anti-fungal, and anti-inflammatory agents and are very well tolerated, and highly efficacious, novel productsthat do not pass through the skin, capable of holding four times their weight in skin secretionsand can absorb skin secretions. Like a true sponge, each microspheres consists of a myriad of interconnecting voids within a non-collapsible structure with a large porous surface. The size of the microsponges can be varied usually from 5-300µm in diameter, depending upon the degree of smoothness or after-feel required for the end formula. Although the microsponge size may vary, a typical 25µm sphere can have up to 250000 pores and an internal pore structure equivalent to 10ft in length providing a total pore volume of about 1ml/g. This results in a large reservoir within each microsponge, which can be loaded with up to its own weight in active agent. The microsponge particles themselves are too large to be absorbed into the skin and this adds a measure of safety to these microsponge materials. Another safety concern is the potential bacterial contamination of the materials entrapped in the microsponge. Because the size of the pore diameter is smaller than bacteria, ranging from 0.007 to 0.2µm, bacteria cannot penetrate into the tunnel structure of the microsponges.The microsponge system can prevent excessive accumulation of ingredients within the epidermis and the dermis. Potentially, the microsponge system can reduce significantly the irritation of effective drugs without reducing their efficacy.

  • OPTIMIZATION FORMULATION AND EVALUATION OF SUSTAINED RELEASE TABLETS OF ASPIRIN AND ATORVASTATIN
    OPTIMIZATION FORMULATION AND EVALUATION OF SUSTAINED RELEASE TABLETS OF ASPIRIN AND ATORVASTATIN

    About Authors:
    Kalpen N. Patel*, Maulika S. Patel, Divya Thakkar, Manan Patel, Kaushal Raval
    Shree Krishna Institute of Pharmacy, Shankhalpur,
    Bechraji, Mahesana, Gujarat, India.
    *kalpenpharma@gmail.com

    ABSTRACT
    Sustained releases tablets have been used for reduced the dosing frequency and maintain the plasma drug concentration level within narrow therapeutic range. Aspirin used as antiplatelate agent and Atorvastatin is HMG-CoA reductase inhibitor which lowers the plasma concentration of cholesterol. Here in present study sustained release tablets of Aspirin and Atorvastatin prepared by using cellulose acetate phthalate (CAP) and microcrystalline cellulose (MCC) as a polymers. The sustain release tablet of Aspirin And Atorvastatin were prepared by wet granulation method and were substituted for film coating to mask the spotting from Atorvastatin and for protection from light. From the dissolution profile of F2B2 gives controlling the release up to 12 hrs with required value i.e. - 55.85 % for Aspirin and 54.78 % for Atorvastatin in 4 hrs respectively and 100.70 % for Aspirin and 100.60 % for Atorvastatin in 12 hrs respectively. The result of stability studies of batch F2B2 indicate that it is stable at 400C / 75 % ±0.5 % relative humidity as there was no significant differences observe for dissolution and average drug content data after two months.

  • A REVIEW ON PLANT DERIVED NATURAL GUMS/POLYMERS IN MUCOADHESIVE DRUG DELIVERY SYSTEM FOR IMPROVING PATIENT COMPLIANCE
    A REVIEW ON PLANT DERIVED NATURAL GUMS/POLYMERS IN MUCOADHESIVE DRUG DELIVERY SYSTEM FOR IMPROVING PATIENT COMPLIANCE

    About Authors:
    Nehal Lakum
    MPharm, Pharmaceutics and Pharmaceutical technology
    nblakum@gmail.com

    ABSTRACT:
    Mucoadhesion can be defined as a state in which two components, of which one is of biological origin are held together for extended periods of time and sustain the effect of drug dosage forms at the site of action. Mucoadhesive drug delivery systems is one of the most promising drug delivery systems with its various advantages and it has a lot of potential in formulating dosage forms for various chronic diseases in which sustained action is required. The current review provides a good insight on advantages of mucoadhesive drug delivary system, characteristics of an ideal mucoadhesive polymer, plant derived Natural mucoadhesive polymers in mucoadhesive drug delivery system for better patient compliance.

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