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FEATURED ARTICLES

  • Outsourcing Solid Dose Manufacturing Trends In 2014
    Outsourcing Solid Dose Manufacturing Trends In 2014

    In 2014, the contract manufacturing market for solid dosage forms is anticipated to be $19.6B, representing 58% of the total CMO market value of $33.7B. While the market value percentage for solid dose has been drifting downward — likely related to the shift towards biologics, which are more expensive to develop and manufacture — the propensity to outsource oral solid dosage forms continues to grow modestly.

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WHITE PAPERS & CASE STUDIES

  • Comparative Human <em>in-vivo</em> Study And The Impact Of The Dissolution Rate On Bioequivalence
    Comparative Human in-vivo Study And The Impact Of The Dissolution Rate On Bioequivalence

    Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.

  • Using QbD For Process Optimization Of A Novel Oral Solid Dosage Form
    Using QbD For Process Optimization Of A Novel Oral Solid Dosage Form

    As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”1 Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”2 that includes ideas such as Quality by Design (QbD) in the development process. This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.

  • Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era
    Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era

    The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.

  • The Effect Of Tablet Porosity On Dissolution
    The Effect Of Tablet Porosity On Dissolution

    Porosity is a characteristic that influences many of the critical quality attributes of finished pharmaceutical products. Porosity can help predict deformation properties during compression, pharmacokinetic behavior within the body, shelf life, moisture penetration, and bioavailability.

  • Excipients: The Unsung Heroes Of Pharmaceuticals
    Excipients: The Unsung Heroes Of Pharmaceuticals

    <p>Excipients are often described as inactive ingredients that assist in the delivery and processing of the active pharmaceutical ingredients. Although this is true, excipients have a much larger influence on final product performance than the term &ldquo;inactive ingredient&rdquo; suggests. In fact, choosing the right excipients is a key determinant of the quality and functionality of a pharmaceutical product.</p>

     

  • Fundamentals Of Spray-Dried Dispersion Technology
    Fundamentals Of Spray-Dried Dispersion Technology

    A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classification System (BCS) class II and IV space, which includes compounds that are dissolution rate, solubility or permeability limited to absorption, or all three. As portfolios across the industry are increasingly focused on these compounds, the need for enabling technologies continues to grow.

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PRODUCTS & SERVICES

Used Fluid Air High Shear Mixer Used Fluid Air High Shear Mixer

One (1) used Fluid Air high shear mixer, model PX1, stainless steel construction, liter bowl, 240 volt on base, serial# 10349.

Franklin Miller Delumper Franklin Miller Delumper

One (1) used Franklin Miller delumper, model DC1075A-S4, sanitary stainless steel construction, approximately 14" x 16" opening, cantilevered design, belt driven by 10 hp, 230/460 volt, 1760 rpm motor, on stainless steel stand with removable stainless steel feed hopper, on board control panel with Allen Bradley MicroLogix 1000 PLC, job# 02-10-07, serial# 6191, build 12/2002.

DeDietrich Powder Transfer System DeDietrich Powder Transfer System

One (1) used Dedietrich powder transfer system, model PTS-100-NH, stainless steel product contact surfaces with filter and recevier, 5 hp Busch vacuum pump, model U064606161, 230/460 volt, Dedeitrich serial# 142156.

Used Korsch 10 Station Tablet Press Used Korsch 10 Station Tablet Press

One (1) used Korsch rotary tablet press, model XL100, 10 station removable turret, B tooled, keyed upper punch guides, 60KN compression pressure with 15 kn pre compression, force feeder and gravity feed design with hopper, 16mm max tablet diameter, rated up to 1000 tablets/minute, 2.2 kw, 220 volt motor, with PMA3 controller, serial# K1510022.

Used Fette Pharma Isolator, Dust Collector Used Fette Pharma Isolator, Dust Collector

One (1) used Fette Absolut isolator dust collector, typ K20/11.5, 800 cfm capacity, 2-stage filtration, lower chamber measures 45" high x 36" wide x 30" deep lower chamber, with 14" diameter x 16" straight side portable bin, (2) glove ports in lower chamber, with 7.5 HP New York Blower pressure blower, 480 volts, serial# 249, built 2006.

Used Fette 36 Station Turret Used Fette 36 Station Turret

One (1) used 36 station Fette turret for model 2090I press, 16 mm max tablet diameter, 18 mm max depth of fill.

Used Fette 75 Station Tablet Press With Containment, 3090i WIP Used Fette 75 Station Tablet Press With Containment, 3090i WIP

One (1) used Fette rotary tablet press, model 3090i WIP and Containment, 75 station segmented turret, 100 Kn pre-compression, 100 Kn main compression pressure, 11, 18, 25 mm max tablet diameter depending on segment spacing, 22 mm max depth of fill, keyed upper and lower punch guides, double sided with force feeders, rated 528,000 -1,080,000 tablets/hour production speeds depending on tablet diameter, 3 phase, 50-60 hertz, 400 volt, mounted in WIP(Wash In Place) containment isolator, with Two (2) Pharmatech Combi 1000i WIP units with deduster and Lock MET30+ metal detectors, 230 volt, mounted in WIP(Wash In Place) containment isolators, with, Fette Checkmaster 4 tablet testing unit, type CM4.1, 100-240 volt, serial# 02100105, operator interface, WIP(Wash In Place) control skid and control panel, Pharmatech serial#'s 0504751, 0504752, Lock serial# 25359-1, 25358-1, Fette serial# 280053, system new in 2005.

Used Fette 37 Station Tablet Press, P3000 Used Fette 37 Station Tablet Press, P3000

ONE (1) Used Fette Perfecta 3000 rotary tablet press, 100 KN total compression with 20 KN pre-compression, 37 station, D tooled, 25 mm max tablet diameter, 22 mm max depth of fill, double sided, keyed upper punch guides, rated up to 266400 tablets/hour, serial# 23343, built 1982.

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