Directly compressed mini-tablets coated in a solid-wall pan for sustained drug release
|
|
- Aubrey Curtis
- 8 years ago
- Views:
Transcription
1 Directly compressed mini-tablets coated in a solid-wall pan for sustained drug release March 2012 N. Passerini, B. Albertini, L.Rodriguez Department of Pharmaceutical Sciences, University of Bologna C. Funaro, G. Mondelli IMA s.p.a. Solid Dose Division
2 Introduction The production of mini-tablets for sustained drug release is a new and promising area of pharmaceutical research. Sustained-release mini-tablets can be produced either as a matrix or by coating the mini-tablets in a fluid bed apparatus. Thus far, the pan-coating of mini-tablets has not Aim of the study The aim of this study was to investigate the possibility of manufacturing a sustained-release multiple dosage Conclusion The results showed that direct compression yielded mini-tablets with a high amount of TH, a low friability and a high crushing strength. Mini-tablets are a multipleunit dosage form, with the following advantages over single-unit dosage forms: low risk of dose dumping, high degree of dispersion in the GI tract and reproducible bioavailability. been extensively implemented; however, this process produces the following advantages over the fluid bed method: increased production capabilities, reduced waste of coating materials and shorter equipment clean-ing time. form by coating directcompression mini-tablets in a solid wall pan. Theophylline was used as a model drug and WAS an innovative ready-to-use pigment dispersion was tested to evaluate the possibility A solid-wall pan proved a suitable technique for mini-tablet coating and the ready-to-mix piment dispersion proved a suitable method for shortening coating suspension preparation time. Moreover, when manufactured by direct compres- of reducing production time. Thus, a sustained-release multiple-dosage form was sion instead of granulation successfully manufac- or extrusion and spheroniza- tured using a tablet press tion, production is comple- and a solid wall pan. ted in one step, with lower costs and higher production yields. p. 1
3 Experiment part Materials Methods Preparation of mini-tablets TH, Avicel PH 102, spray-dried lactose and magnesium stearate (total 4 kg per batch) were blended using an IMA Cyclops Methods Coating of mini-tablets Each batch of 10 kg mini-tablets was coated in an IMA GS 25 L solid-wall pan. Two different coating formulae were used: a traditional formula containing single components to be dissolved in water before use (A) and the WAS ready-to-use pigment dispersion (B). Theophylline (TH, particle lower than 100 microns) was purchased from BASF, Ludwigshafen, Germany. Avicel PH 102 was kindly supplied by FMC Biopolymer Brussels, Belgium. Spray-dried lactose, magnesium stearate, talc, titanium dioxide, trietilcitrate and Yellow Quinoline (all FU-grade) were purchased blender. Direct compression was performed using IMA Pressima, a tablet press machine for R&D and small batches, equipped with 2 EU-D punches fitting 24 mini-punches, each 2 mm in diameter. The compression force used to obtain 9 mg mini-tablets was 20 kn for all batches, with a 25-rpm fill shoe speed. from Polichimica, in Bologna, Italy, and used as received. Eudragit RL, Eudragit RS (polymer conforming to Ammonio Methacrylate Copolymer, Type A USP/NF 31) and WAS (containing talc, Titanium dioxide, Yellow Quinoline and Trietilcitrate) were kindly supplied by Rofarma Italia, in Milano, Italy. 2 EU-D punch fitting several mini-punches p. 2
4 Methods Coating of mini-tablets Characterization croscopy (SEM ESEM-FEI Quanta 200). The actual drug content and in-vitro drug release profiles Both formulae were tested at different polymer amounts expressed in total solids weight gain percentage. Process parameters for formulae A and B are described in the table. The mini-tablets (mt) were tested for uniformity of mass, friability (using the Roche friabilator) and crushing strength (TBH 200, Erweka, Germany) and the sur- of the coated mini-tablets (CmT) were characterized (USP paddle method, 50 rpm, 900 ml ph 7.4 phosphate buffer at 37 C). The analysis was performed spectro- face characteristics were obser- photometrically (UV2, Unicam) ved using Scanning Electron Mi- at nm Result and discussion containing different amounts of the drug were produced in order to determine the formulation which had mechanical properties suitable for pan- In the first part of the study, four batches of mini-tablets coating, minimal weight variation and maximum drug content. * The mixture of excipients contains: spray-dried lactose 60%, Avicel PH %, magnesium stearate 1%. p. 3
5 All the mts produced had When comparing the opera- As shown in the figure, the un- to the coating level. At the same technological properties suit- tive parameters used in coating, coated mt released 100% of coating level, the dissolution pro- able for coating (high crushing it is evident that the coating the active ingredients in less files of both formulae were not strength and very low friability) conditions for formula A and B than 90 minutes. significantly different, suggesting and complied with the test for were very similar. Sustained release was ensur- that the ready-to-use system is uniformity of mass, according ed by both formulae and all equivalent to the traditional one. to European Pharmacopoeia. This demonstrates the inter- polymer amounts, proportionate Batch mt4 was then selected changeability of the traditional for coating due to its high drug formula containing single com- content. ponents with the ready-to-use pigment dispersion. The second part of the study was aimed at demonstrating The SEM photographs of un- the feasibility of coating mts in coated mt4 and coated mts a solid wall pan and to test the at different levels show that a possibility of replacing the stan- complete, uniform layer was dard coating preparation with a achieved using both formulae, ready-to-use system. even at a low coating level. Dissolution of uncoated and coated mt (formula A and B) at different total solids weight gain. p. 4
Generic Drug Formulations. with. and. Kollidon SR
Generic Drug Formulations with Kollicoat SR 3 D and Kollidon SR Contents I. Kollicoat SR 3 D Coating 1.1 Theophylline sustained-release pellets 1.2 Theophylline sustained-release pellets (drug-layering
More informationSolid dosage forms testing: Disintegration test and tablet friability and hardness
Specialized Laboratory for Drug production (N111049) Instructions Solid dosage forms testing: Disintegration test and tablet friability and hardness Tutor: Ing. Jiří Petrů Study program: Drug synthesis
More informationTable 1. Pure superdisintegrant tablet formulation. Material % w/w Weight (mg) Superdisintegrant 99 277.2 Stearic acid 1 2.
PHARMACEUTICAL TECHNOLOGY REPORT Ashland Specialty Ingredients ashland.com PTR-95 Page 1 of 5 Utility of Polyplasdone as a Tablet Binder Quyen Schwing, Marvin Davis, Divya Tewari, Thomas Dürig Ashland
More informationSTARCH 1500. Application Data
STARCH 1500 Application Data Partially Pregelatinized Maize Starch Starch 1500, Partially Pregelatinized Maize Starch, Used as a Binder Disintegrant in High Shear Wet Granulation Comparison to Povidone
More informationThe importance of normalisation when comparing tablet properties
The importance of normalisation when comparing tablet properties Tablet quality definition The properties of a tablet, both during manufacturing and in vivo, are determined by the properties of the materials
More informationFormulation and Evaluation of Didanosine Enteric Coated Sustained Release Tablet
Formulation and Evaluation of Didanosine Enteric Coated Sustained Release Tablet K. L. Senthil Kumar*, S. Ashokkumar, R. P. Ezhilmuthu Dept of Pharmaceutics, Padmavathi College of Pharmacy and Research
More informationIt is an important tool to assess factors that affect the bioavailability of a drug from a solid preparartion.
Quality control of tablets Dissolution It is an important tool to assess factors that affect the bioavailability of a drug from a solid preparartion. To ensure that the preparation comply with product
More informationPerformance Evaluation of Actimask 92S Ibuprofen: A Novel Taste-Masked Ibuprofen for Use in Orally-Dispersible Dosage Forms
Performance Evaluation of Actimask 92S Ibuprofen: A Novel Taste-Masked Ibuprofen for Use in Orally-Dispersible Dosage Forms Author: Brian D. Wilson Background Recently, orally-dispersible dosage forms,
More informationVinod et al., ARPB, 2013; Vol 3 (II) ISSN 2250-0774
Vinod et al., ARPB, 2013; Vol 3 (II) ISSN 2250- (RESEARC ARTICLE) QUALIFICATION OF EQUIPMENT: SAIZONER MIXER GRANULATOR, COMPRESSION MACINE AND COATING PAN * J. Vinod and A. Chenthilnathan Department of
More informationFORMULATION EVALUATION AND OPTIMIZATION OF AN ORAL IMMEDIATE RELEASE ANTIBIOTIC FORMULATION OF AMOXICILLINE
e-issn 2249 7706 print-issn 2249 7714 International Journal of Advanced Pharmaceutics www.ijapjournal.com FORMULATION EVALUATION AND OPTIMIZATION OF AN ORAL IMMEDIATE RELEASE ANTIBIOTIC FORMULATION OF
More informationTABLET REFORMULATION CASE STUDY. Executive Summary
TABLET REFORMULATION Executive Summary A large European pharmaceutical company contracted Aptuit to reformulate a tablet with existing dosage strengths of 25 mg and 50 mg. The client required smaller strengths
More information2.3 QUALITY OVERALL SUMMARY Sakura Tablet
English Mock QOS P2_Final_June08 MODULE 2: COMMON TECHNICAL DOCUMENT SUMMARIES Generic name: Amokinol 2.3 QUALITY OVERALL SUMMARY Sakura Tablet 1 English Mock QOS P2 Final TABLE OF CONTENTS Page Table
More informationHigh Performance Dry Binding with CELNY-SSL Super Fine Powder
CELNY TM hydroxypropyl cellulose for nutraceutical & food use NOTE #: APPLICATION: CELNY-SSL-SFP-1 Direct Compression/ ODT Formulation High Performance Dry Binding with CELNY-SSL Super Fine Powder APPLICATION
More informationResearch Article Prospective Validation of Paracetamol Tablet Dosage Form
Research Article Prospective Validation of Paracetamol Tablet Dosage Form Nidhi Aswal *, Pallavi Joshi, Alka N Choudhary and Preeti Kothiyal Department of Quality Assurance, Shri Guru Ram Rai Institute
More informationResearch Journal of Pharmaceutical, Biological and Chemical Sciences
Research Journal of Pharmaceutical, Biological and Chemical Sciences Development of Tablet Medical Form Containing Substance FS-1. A.S. Kalykova a,c *, D. Vetchy b, and Z.B. Sakipova a. a S.D. Asfendiyarov
More information11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07
In-process control In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 Here you will find answers to the following questions: What are the in-process control tasks? Where
More informationGuide to Inspections of Tablet Manufacturing Facilities including Pre/Post Approval Issues as per USFDA
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.4, No.1, pp 49-55, Jan-Mar 2012 Guide to Inspections of Tablet Manufacturing Facilities including Pre/Post Approval
More informationQuality by Design for ANDAs: An Example for Modified Release Dosage Forms
Quality by Design for ANDAs: An Example for Modified Release Dosage Forms Introduction to the Example This is an example pharmaceutical development report illustrating how ANDA applicants can move toward
More informationThe Story of Magnesium Stearate as a Powder and a Tablet Lubricant
The Story of Magnesium Stearate as a Powder and a Tablet Lubricant Presented by Doug Lugge Director, API Development and Engineering Mallinckrodt What Are Customers Looking for in Selecting Pharmaceutical
More informationPRODUCT DEVELOPMENT GUIDE
PRODUCT DEVELOPMENT GUIDE PRE-FORMULATION - TABLETS Introduction Guidelines for the development of a ANDA product for the US market, Note: some tests or procedures may be unnecessary. The order of performing
More informationQbD Understanding How Excipient Properties Influence Solid Oral Dosage Form Performance
QbD Understanding How Excipient Properties Influence Solid Oral Dosage Form Performance Dr Amina Faham (Dow), Dr Liz Meehan (AstraZeneca) ExcipientFest, Amsterdam NL June 24, 2014 What do you understand
More informationIN VITRO BINDING BIOEQUIVALENCE STUDY SUMMARY TABLES AND SAS TRANSPORT FORMATTED TABLES FOR DATASET SUBMISSION
IN VITRO BINDING BIOEQUIVALENCE STUDY SUMMARY TABLES AND SAS TRANSPORT FORMATTED TABLES FOR DATASET SUBMISSION I. For Calcium Acetate Drug Products Table I.1 Submission Summary * Drug Product Name Strength(s)
More informationPOLYOX. Application Data
POLYOX Application Data Water Soluble Resins The Influence of In Vitro Dissolution Method on the Release of a Highly Water Soluble Drug from Polyethylene Oxide and Hypromellose Hydrophilic Extended Release
More informationCHARACTERIZATION AND EVALUATION OF OKRA GUM AS A TABLET BINDER
Jundishapur Journal of Natural Pharmaceutical Products 28; 3(1): 33-38 Jundishapur Journal of Natural Pharmaceutical Products CHARACTERIZATION AND EVALUATION OF OKRA GUM AS A TABLET BINDER Tavakoli N 1*,
More information2Technical Support 3Formulation Development 4Proof of Concept 5 GMP Services 6Advanced Drug Delivery 1EUDRAGIT Products Evonik. Power to create.
GMP Services Solutions for Clinical Sample Manufacturing 1 EUDRAGIT Products 2 Technical Support 3 Formulation Development Proof of Concept 4 5 GMP Services 6 Advanced Drug Delivery Evonik. Power to create.
More informationUniformity of Dosage Units (BP 2011 & USP 34) Ms. Witinee Kongsuk Bureau of Drug and Narcotic Department of Medical Sciences June 14, 2011
Uniformity of Dosage Units (BP 2011 & USP 34) Ms. Witinee Kongsuk Bureau of Drug and Narcotic Department of Medical Sciences June 14, 2011 1 Outline : Definition Harmonized general chapter USP 34
More informationTHE PHARMACEUTICAL INDUSTRY
TE PARMACEUTICAL INDUSTRY The pharmaceutical industry in New Zealand takes the active ingredients of drugs (which are imported from overseas) and converts them into a form that can easily be given to a
More informationInternational Research Journal of Pharmaceutical and Applied Sciences Available online at www.irjpas.com. Int. Res J Pharm. App Sci.
International Research Journal of Pharmaceutical and Applied Sciences Available online at www.irjpas.com Int. Res J Pharm. App Sci., 2012; 2(4):1-16 Research Article Process Validation of Benazepril HCl
More informationPREPARATION AND EVALUATION OF STARCH PHOSPHATE- A NEW MODIFIED STARCH AS A DISINTEGRANT IN TABLET FORMULATIONS
Int. J. Chem. Sci.: 9(2), 2011, 889-899 Int. J. Chem. Sci.: ISSN 9(1), 0972-768X 2011, 1-11 www.sadgurupublications.com PREPARATIN AND EVALUATIN F STARCH PHSPHATE- A NEW MDIFIED STARCH AS A DISINTEGRANT
More informationGuidance for Industry
Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
More informationTamsulosin Hydrochloride Capsules
. nal Revision Bulletin Official October 1, 2011 Tamsulosin 1 standard solution, and shake well. Centrifuge at 1500 rpm for 10 min, and use the supernatant, passing it if Tamsulosin Hydrochloride Capsules
More informationFormulation and evaluation of enteric coated tablet of Ilaprazole
Rathore et al., International Current Pharmaceutical Journal, June 2013, 2(7): 126-130 http://www.icpjonline.com/documents/vol2issue7/04.pdf International Current Pharmaceutical Journal ORIGINAL RESEARCH
More informationHigh Performance Dry Binding with HPC-SSL Super Fine Powder
NOTE #: Application: DC-ODT-2 Direct Compression/ ODT Formulation High Performance Dry Binding with HPC-SSL Super Fine Powder Application note Introduction (Super Fine Powder), a highly compressible grade
More informationScuffing Measurement Methodology and Improved Film Coating Systems
OPADRY II Application Data High Performance Film Coating System Scuffing Measurement Methodology and Improved Film Coating Systems PURPOSE Scuffing is a term used to describe coated tablet defects consisting
More informationJournal of Chemical and Pharmaceutical Research
Available on line www.jocpr.com Journal of Chemical and Pharmaceutical Research ISSN No: 0975-7384 CODEN(USA): JCPRC5 J. Chem. Pharm. Res., 2010, 2(5): 548-554 Formulation and stabilization of Atorvastatin
More informationEP 2 308 472 A1 (19) (11) EP 2 308 472 A1 (12) EUROPEAN PATENT APPLICATION. (43) Date of publication: 13.04.2011 Bulletin 2011/15
(19) (12) EUROPEAN PATENT APPLICATION (11) EP 2 8 472 A1 (43) Date of publication: 13.04.11 Bulletin 11/ (21) Application number: 0901264.1 (1) Int Cl.: A61K 9/14 (06.01) A61K 9/16 (06.01) A61K 9/ (06.01)
More informationAsian Journal of Research in Biological and Pharmaceutical Sciences Journal home page: www.ajrbps.com
Research Article ISSN: 2349 4492 Asian Journal of Research in Biological and Pharmaceutical Sciences Journal home page: www.ajrbps.com IMPROVEMENT OF SOLUBILITY OF OMEPRAZOLE MAGNESIUM BY SOLID DISPERSION
More informationSPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT
SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption
More informationEUDRAGIT E 100, EUDRAGIT E PO and
Technical Information EUDRAGIT E 100, and Specification and Test Methods Ph. Eur. USP/NF JPE Basic Butylated Methacrylate Copolymer Amino Methacrylate Copolymer - NF Aminoalkyl Methacrylate Copolymer E
More informationIntroduction to Enteris BioPharma
Introduction to Enteris BioPharma Enteris BioPharma Intelligent Solutions for Oral Drug Delivery Privately held, New Jersey based biotech company Owned solely by Victory Park Capital, a large Chicago based
More informationInfluence of the Changed USP Specifications on Disintegration Test Performance
dx.doi.org/10.14227/dt170110p6 Influence of the Changed USP Specifications on Disintegration Test Performance e-mail: Raimar@ualberta.ca Katja Schmid 1 and Raimar Löbenberg 2 * 1 Department of Pharmacy
More informationProcess Validation Protocol (Reference: SOP )
Project Name Equipment Manufacturer Process Line/Location Project Number Serial Number Model Number Protocol number [Enter Product Title, Number & Strength] MULTI VITAMIN TABLETS PRODUCT CODE: Name: Position:
More informationCorso di Laurea Magistrale in Farmacia
Universita degli Studi di Milano Corso di Laurea Magistrale in Farmacia Tecnologia e Legislazione Farmaceutiche I - 9 CFU Prof. Andrea Gazzaniga Rilascio Modificato Orale Ritardato/Pulsatile Parte II Swelling
More informationResearch needs in pharmaceutical excipients: implications of a global supply chain
Research needs in pharmaceutical excipients: implications of a global supply chain FY 2015 GDUFA Regulatory Science Initiatives Part 15 Public Meeting June 5, 2015 Silver Spring, MD Stephen W. Hoag, Ph.D.
More informationTableting Punch Performance Can Be Improved With Precision Coatings
Tableting Punch Performance Can Be Improved With Precision Coatings by Arnold H. Deutchman, Ph. D. Director of Research and Development (614) 873-4529 X 114 adeutchman@beamalloy.net Mr. Dale C. Natoli
More informationBundesinstitut für Arzneimittel und Medizinprodukte. Dissolution Testing. Analytik,Methodenentwicklung, Bioäquivalenz SAQ. Olten, 25.
Dissolution Testing Analytik,Methodenentwicklung, Bioäquivalenz SAQ Olten, 25. Januar 2006 Dr. H. Potthast (h.potthast@bfarm.de) 1 2 Basis for Biowaiver Applications/Decisions Note for Guidance on the
More informationGENERAL GUIDANCE FOR INSPECTORS ON HOLD-TIME STUDIES
February 2013 RESTRICTED GENERAL GUIDANCE FOR INSPECTORS ON HOLD-TIME STUDIES DRAFT FOR COMMENT Should you have any comments on the attached text, please send these to Dr Sabine Kopp, Manager, Medicines
More informationMostly, for a conventional dosage form the dosing i ntervals of the drug are much less than the drug half life leads to numerous limitations.
CHAPTER 5: SUMMARY AND CONCLUSION 5.1. SUMMARY AND CONCLUSION: Major challenge to controlled/sustained release drug deli very system is to uphold the drug delivery system at exacti ng site for extensive
More informationUNIVERSITY OF PARMA INTERDEPARTMENTAL CENTRE FOR INNOVATION IN HEALTH PRODUCTS, BIOPHARMANET-TEC
UNIVERSITY OF PARMA INTERDEPARTMENTAL CENTRE FOR INNOVATION IN HEALTH PRODUCTS, BIOPHARMANET-TEC RULES FOR THE USE OF THE CENTER EQUIPMENTS ACQUIRED WITHIN THE AGREEMENT BETWEEN THE UNIVERSITY OF PARMA
More informationColours in Pharmaceutical Products
Colour Management For Formulators 23 rd October 2013 Colours in Pharmaceutical Products Marcel Cimpan Senior Manager Customer and Technical Services Agenda Uses for colours in the Pharmaceutical industry
More informationOverview of Dissolution for BA/BE
Biopharmaceutics Classification System based on Solubility/Permeability Biowaivers for BCS I Drugs Discussion of BCS III Drugs Models establishing in vivo-in vitro Correlations (IVIVC Levels A-C) 1 Biopharmaceutics
More informationEffect of Filler Type on the Stability of Polyethylene Oxide in a Hydrophilic Matrix Tablet
Effect of Filler Type on the Stability of Polyethylene Oxide in a Hydrophilic Matrix Tablet Jennifer L Hote-Gaston (jlhote@dow.com) and Dave Wallick The Dow Chemical Company, Dow Wolff Cellulosics, Larkin
More informationReversed Phase High Presssure Liquid Chromatograhphic Technique for Determination of Sodium Alginate from Oral Suspension
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.2, No.2, pp 1634-1638, April-June 2010 Reversed Phase High Presssure Liquid Chromatograhphic Technique for Determination
More informationINTERNATIONAL RESEARCH JOURNAL OF PHARMACY www.irjponline.com ISSN 2230 8407 Research Article
INTERNATIONAL RESEARCH JOURNAL OF PHARMACY www.irjponline.com ISSN 2230 8407 Research Article PREPARATION AND EVALUATION OF TIMOLOL MALEATE MUCOADHESIVE BUCCAL TABLETS Adimoolam Senthil*, Chauhan Pratik
More informationINTERNATIONAL RESEARCH JOURNAL OF PHARMACY www.irjponline.com ISSN 2230 8407 Review Article
INTERNATIONAL RESEARCH JOURNAL OF PHARMACY www.irjponline.com ISSN 2230 8407 Review Article INDUSTRIAL PROCESS VALIDATION OF TABLET DOSAGE FORM: AN OVERVIEW Gupta Surbhi 1 *, Saini Seema 1, Singh Gurpreet
More informationkalox-pool draft 231 repairing refurbishing and finishing KALOX-POOL Waterproof cement-based mortar for protecting and finishing concrete.
kalox-pool draft 231 KALOX-POOL Waterproof cement-based mortar for protecting and finishing concrete. repairing refurbishing and finishing 8-30 C Trowel / Spray 4 mm kalox-pool EN 1504-2 MAIN FEATURES
More informationTop and Bottom Spray Fluid Bed Granulation Process
Top and Bottom Spray Fluid Bed Granulation Process Use of Lasentec FBRM In-Process Particle Sizing PAT Technique to Study Top and Bottom Spray Fluid Bed Granulation Process Presented November 10, 2005
More informationMaking Improvement Work in Pharmaceutical Manufacturing Some Case Studies. Ronald D. Snee
Making Improvement Work in Pharmaceutical Manufacturing Some Case Studies Ronald D. Snee ISPE Midwest Extended Education and Vendor Day Overland Park, KS 2 May 2007 King of Prussia PA New York NY Washington
More informationGeneric drugs are copies of innovator drug products
dx.doi.org/10.14227/dt190412p51 In Vitro Equivalence Studies of Generic Metformin Hydrochloride Tablets and Propranolol Hydrochloride Tablets Under Biowaiver Conditions in Lagos State, Nigeria e-mail:
More informationEvaluating the Effects of Tablet Characteristics on Enteric Tablet Coating in the Novel Supercell TM Coater
Evaluating the Effects of Tablet Characteristics on Enteric Tablet Coating in the Novel Supercell TM Coater 1. Abstract A Birkmire and K Walter Niro Pharma Systems, Columbia, MD USA In the pharmaceutical
More informationINTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES Formulation and evaluation of intragastric buoyant tablets of amoxicillin trihydrate
INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES Formulation and evaluation of intragastric buoyant tablets of amoxicillin trihydrate A. Kotwal * and A.K. Pathak Department of Pharmacy, Barkatullah University,
More informationAll the prepared formulations were subjected for following. evaluation parameters and obtained results were showed in Tables 6.3 &
105 6.1 CHARACTERIZATION OF TABLETS All the prepared formulations were subjected for following evaluation parameters and obtained results were showed in Tables 6.3 & 6.4. 6.1.1 Description (Size, Shape,
More informationDissolution Rate Enhancement of Fenofibrate Using Liquisolid Tablet Technique. Part II: Evaluation of In Vitro Dissolution Profile Comparison Methods.
Latin American Journal of Pharmacy (formerly Acta Farmacéutica Bonaerense) Lat. Am. J. Pharm. 28 (4): 538-43 (2009) Original Article Received: March 1, 2009 Accepted: April 9, 2009 Dissolution Rate Enhancement
More informationFRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT VIRBAKOR 20 mg film-coated tablet for dogs Date: 03/11/2014 French agency for food, environnemental
More informationGuidance for Industry
Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
More informationContinuous Granulation and Drying
Continuous Granulation and Drying Collette TM Technologies GEA Pharma Systems GEA Pharma Systems supplies advanced technologies for the processing of Active Pharmaceutical Ingredients (API) for the production
More informationANALYTICAL METHODS INTERNATIONAL QUALITY SYSTEMS
VALIDATION OF ANALYTICAL METHODS 1 GERT BEUVING INTERNATIONAL PHARMACEUTICAL OPERATIONS TASKS: - Internal auditing - Auditing of suppliers and contract manufacturers - Preparing for and guiding of external
More informationLacidipine 2 mg Film-Coated Tablets PL 08553/0502. Lacidipine 4 mg Film-Coated Tablets PL 08553/0503. UK Public Assessment Report
Lacidipine 2 mg Film-Coated Tablets PL 08553/0502 Lacidipine 4 mg Film-Coated Tablets PL 08553/0503 UK Public Assessment Report TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken
More informationPOLYOX. Application Data. Formulation of POLYOX ER Matrices for a Highly Soluble Active APPLICATIONS DATA SUMMARY INTRODUCTION POLYOX - 1 -
POLYOX Application Data Water Soluble Resins Formulation of POLYOX ER Matrices for a Highly Soluble Active APPLICATIONS DATA SUMMARY POLYOX, water soluble resins (WSR), can be used as an alternative to
More informationREMOVAL OF PHOSPHATE FROM WASTEWATER USING LOW-COST ADSORBENTS
International Journal of Engineering Inventions ISSN: 2278-7461, www.ijeijournal.com Volume 1, Issue 7 (October2012) PP: 44-50 REMOVAL OF PHOSPHATE FROM WASTEWATER USING LOW-COST ADSORBENTS Dr. C.R.Ramakrishnaiah
More information[See Rules 74,74-A, 74-B, 78 and 78-A] A. SUBSTANCES OTHER THAN PARENTERAL IN PREPARATIONS IN GENERAL
29 [SCHEDULE U [See Rules 74,74-A, 74-B, 78 and 78-A] I. Particulars to the shown in /manufacturing Records A. SUBSTANCES OTHER THAN PARENTERAL IN PREPARATIONS IN GENERAL 1. Serial number. 2. Name of the
More informationWhat to Look for in Statistical Software for the Pharmaceutical Industry
What to Look for in Statistical Software for the Pharmaceutical Industry Statistical methods are becoming increasingly important for the pharmaceutical industry. The FDA and other regulatory and standard-setting
More informationMACS Lab, Inc. Phone: (408) 727-9727 FAX: (408) 727-7065 2070A Walsh Ave www.macslab.com 1-800-MACS LAB (1-800-622-7522 Santa Clara, CA 95050-2542
MACS Lab, Inc. Phone: (408) 727-9727 FAX: (408) 727-7065 2070A Walsh Ave www.macslab.com 1-800-MACS LAB (1-800-622-7522 Santa Clara, CA 95050-2542 Material Analysis and Characterization Service MACS Lab,
More informationAMBERLITE IRP69 Pharmaceutical Grade Cation Exchange Resin (Sodium Polystyrene Sulfonate USP)
AMBERLITE IRP69 Pharmaceutical Grade Cation Exchange Resin (Sodium Polystyrene Sulfonate USP) Description AMBERLITE IRP69 [1] resin is an insoluble, strongly acidic, sodium form cation exchange resin supplied
More informationVol. 4, Issue 3, 2011 ISSN - 0974-2441 FORMULATION AND EVALUATION OF ESOMEPRAZOLE DELAYED RELEASE TABLETS TUSHAR G. RUKARI 1 *, GANESH V.
Academic Sciences Asian Journal of Pharmaceutical and Clinical Research Vol 6, Issue, 203 ISSN - 0974-244 Research Article Vol. 4, Issue 3, 20 ISSN - 0974-244 FORMULATION AND EVALUATION OF ESOMEPRAZOLE
More informationEFFECT OF DIFFERENT BIOADHESIVE POLYMERS ON PERFORMANCE CHARACTERISTICS OF VAGINAL TABLETS
EFFECT OF DIFFERENT BIOADHESIVE POLYMERS ON PERFORMANCE CHARACTERISTICS OF VAGINAL TABLETS Tambwekar K. R., Gunjan, Vermani K., Kandarapu R., Zaneveld L. J. D., and Garg S. National Institute of Pharmaceutical
More informationIn situ Fiber Optic Dissolution Monitoring of a Vitamin B 12 Solid Dosage Formulation
dx.doi.org/10.14227/dt100403p20 In situ Fiber Optic Dissolution Monitoring of a Vitamin B 12 Solid Dosage Formulation Christopher J. Toher 2,Per E. Nielsen 2, Alexis S. Foreman 1, 2,Alex Avdeef 2 email
More informationComparative Assessment of the Quality Control Measurements of Multisource Ofloxacin Tablets Marketed in Nigeria
dx.doi.org/10.14227/dt170210p20 Comparative Assessment of the Quality Control Measurements of Multisource Ofloxacin Tablets Marketed in Nigeria e-mail: jdjide@yahoo.com Sunday O. Awofisayo 1, *, Oladoja
More informationPalasurance SPDD Granulated Enhances Palatability and Tableting Performance in Companion Animal Supplements Technical Services
Palasurance SPDD Granulated Enhances Palatability and Tableting Performance in Companion Animal Supplements Technical Services KEY CONCLUSIONS: KEY CONCLUSIONS: Palasurance SPDD Granulated is a dry palatant
More informationJune 2010 Pharmacy Professional
f e at u r e s p e c i a l s Dealing with specials Responding to members requests the Society presents practical guidance for pharmacists on professional responsibilities when dealing with the supply of
More information- KOBAYASHI ZEIN DP -
Zein is a major component of corn proteins, called a prolamine soluble in aqueous ethanol. Zein is extracted from gluten meal separated under corn starch production. The acquisition of deodorized and decolourised
More informationPROCESS VALIDATION OF TABLETS: AN OVERVIEW
PROCESS VALIDATION OF TABLETS: AN OVERVIEW Vikas Verma 1*, Ujjwal Nautiyal 1, M. Senthil Kumar 1, Chandra Kant 1 1 Department of Pharmacy, Himachal institute of Pharmacy, Paonta Sahib, (H.P), India. ABSTRACT
More informationInternational Journal of Pharma and Bio Sciences PHARMACEUTICAL EVALUATION AND COMPARISON OF VARIOUS BRANDS OF PARACETAMOL TABLET FORMULATION.
Research Article Pharmacology International Journal of Pharma and Bio Sciences ISSN 0975-6299 PHARMACEUTICAL EVALUATION AND COMPARISON OF VARIOUS BRANDS OF PARACETAMOL TABLET FORMULATION. DR SHREENIVAS.
More informationPublic Assessment Report UKPAR
Public Assessment Report UKPAR Amitriptyline 10 mg film-coated tablets Amitriptyline 25 mg film-coated tablets Amitriptyline 50 mg film-coated tablets (Amitriptyline hydrochloride) UK Licence No: PL 17907/0131-133
More informationGuidance for Industry
Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products General Considerations U.S. Department of Health and Human Services Food and Drug Administration Center
More informationGuidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding
More informationEuropean Continuing Education College
Design and Development of Conventional and Modified Release Oral Drug Delivery Systems Three Day Intensive Course for Managers, Scientists and Technicians with the Emphasis on the Principles of Oral Drug
More informationRESEARCH ARTICLE PREPARATION AND EVALUATION OF LEVOFLOXACIN HEMIHYDRATES FLOATING TABLETS
JOUN OF U IVY SCH SCH TIC PPTION N VUTION OF VOFOXCIN HMIHYTS FOTIN TBTS YK Y.B* 1, Sai kishore.v 2, TejaKrishna.M 1, Prasada ao. K.V.S. 1 1. ahul institute of Pharmaceutical Sciences and esearch,chirala.
More informationInternational Journal of Pharmaceutical Research & Analysis
193 International Journal of Pharmaceutical Research & Analysis e-issn: 2249 7781 Print ISSN: 2249 779X www.ijpra.com FORMULATION AND EVALUATION OF ENTERIC COATING TABLETS BY WET GRANULATION METHOD B.Shibu
More informationPublic Assessment Report. Decentralised Procedure. Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated. Sildenafil citrate UK/H/4855/001-3/DC
Public Assessment Report Decentralised Procedure Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated Sildenafil citrate UK licence no: PL 08553/0468-70 DR Reddy s Laboratories (UK) Limited 1 LAY SUMMARY
More informationEvaluation of Dissolution Hydrodynamics in the USP, Peak and Flat-Bottom Vessels Using Different Solubility Drugs
dx.doi.org/10.14227/dt120105p11 Evaluation of Dissolution Hydrodynamics in the USP, Peak and Flat-Bottom Vessels Using Different Solubility Drugs Tahseen Mirza, Ph.D., Yatindra Joshi, Ph.D, Qian (Julie)
More informationThe potential impact of concomitant alcohol consumption
dx.doi.org/10.14227/dt210114p11 Effect of Alcohol on Drug Release Kinetics from HPMC-Based Matrix Tablets Using Model Drugs e-mail: prof_avachat@yahoo.com Amelia M. Avachat* and Dinesh S. Nandare Department
More informationThe identification of tablets and capsules containing barbiturates by MATR infrared spectroscopy
J. Pharm. Pharmac., 1971,23,781-785 Recehled February 23, 1971 The identification of tablets and capsules containing barbiturates by MATR infrared spectroscopy J. E. ATKINSON The School of Pharmacy, Robert
More informationhttp://www.propharmacia.pl 1
Basic criteria for paediatric formulations Oral paediatric formulations problems, ideas and research Warszawa, Poland March 6, 2013 Prof. Dr. Jörg Breitkreutz Institute ofpharmaceutics and Biopharmaceutics
More informationANALYTICAL METHOD DEVELOPMENT FOR DISSOLUTION RELEASE OF FINISHED SOLID ORAL DOSAGE FORMS
Academic Sciences International Journal of Current Pharmaceutical Research ISSN- 0975-7066 Vol 4, Issue 2, 2012 Research Article ANALYTICAL METHOD DEVELOPMENT FOR DISSOLUTION RELEASE OF FINISHED SOLID
More informationParticle Surface Area
Particle Surface Area TM Introducing the Acorn Area TM The Acorn Area TM is a revolutionary instrument designed to measure the surface area of nanoparticles dispersed in a liquid. This patented nuclear
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 29 July 1999 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON QUALITY OF MODIFIED
More informationPublic Assessment Report Scientific discussion. Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921
Public Assessment Report Scientific discussion Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921 This module reflects the scientific discussion for the approval of
More informationPublic Assessment Report. Scientific discussion. Desloracell 5 mg, film-coated tablet. (desloratadine) NL License RVG: 112807
Public Assessment Report Scientific discussion Desloracell 5 mg, film-coated tablet (desloratadine) NL License RVG: 112807 Date: 6 July 2015 This module reflects the scientific discussion for the approval
More informationPharmaceutical Quality Systems: US Perspective
Pharmaceutical Quality Systems: US Perspective Rick Friedman Associate Director, Office of Manufacturing and Product Quality Center for Drug Evaluation and Research Topics Background: The ICH Q10 Pharmaceutical
More information