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Cetero Research	The Cadaver Skin Absorption Model and The Drug Development Process A crucial element in the development of topical and transdermal drug products is evaluation of the percutaneous absorption of the active pharmaceutical ingredient (API). Generally, the goal for topical products is to maximize cutaneous delivery of the API, whereas for transdermal products the goal is to achieve a specific rate of absorption sufficient to achieve a systemic blood level within the ...

Thermo Scientific Portal Optical Analyzers	Handheld Instruments for Raw Material Testing; From the Lab to the Loading Dock The purpose of this paper is to discuss the application of Raman spectroscopy to the unique requirements of raw material testing. In order to do so we will answer the following questions: 1. What is and why perform identity testing? 2. What are the incentives to speed up testing? 3. Should we consider modifying the testing process? 4. How does the Thermo Scientific TruScan handheld Raman ...

Patheon Inc.	Advantages of Pharmaceutical Manufacturing in Puerto Rico In an era characterized by the need to continuously evaluate and bolster R&D pipelines, the increasing complexity and overall cost to develop and approve drug products, the trend toward genericization, and mounting pressures to both decrease prices and maximize profitability, the pharmaceutical industry has sought competitive advantage in lower cost manufacturing jurisdictions. The ...

ABC Laboratories	Management of Leachable Compounds Throughout the Lifecycle of an Inhalation ... A database coupled to a statistical analysis program is an effective means for defining a control space, determining process capability of components, establishing specifica- tions for components and drug product and potentially correlating leachable levels to component extractable levels.

Beckloff Associates	Orphan Drug Program Whitepapter The U.S. Orphan Drug Act was signed into law in 1983 and for the first time, provided incentives for the pharmaceutical industry to develop drugs that otherwise had minimal commercial return on investment, but which are necessary, and often life-saving, for patients with rare diseases. The Orphan Drug Act is codified in 21 CFR Part 316. There are approximately 6000 rare disorders affecting ...

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Drug Delivery Research Library

TransDermal Technologies, Inc.	Liquid Transdermal Drug Delivery: The State of the TDS® Art To date, transdermal delivery has been effective in delivering only a very few drugs due to difculties in moving larger, and chemically non-compatible, molecules across the skin's biologically-active barrier. Drugs with higher melting points, drugs of molecular weight greater than 500 Daltons and drugs requiring pharmacological doses of more than 40 mg in 24 hours can not employ patch- or ...

Covance	Clearing the Air: Critical Consideration in Inhalation Toxicology The approval by the Food and Drug Administration (FDA) of the first inhaled insulin combination product for treatment of diabetes represents a milestone in drug delivery. Exubera is an inhaled powder form of recombinant human insulin (rDNA) used in the treatment of adult patients with type 1 and type 2 diabetes and is the first new delivery option introduced since the discovery of insulin in the ...

Lancaster Laboratories	Lancaster Labs develops extractables/leachables database The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices and components utilized in the manufacturing of the product. Packaging includes components such as vials, caps and stoppers. Drug delivery devices include nebulizers, syringes, medical devices and various types of inhalers. ...

Hyaluron - A Subsidiary of AMRI	Solutions for All Your Aseptic Parenteral Drug Formulation/Filling Needs The advent of bubble elimination in a prefilled syringe offers many advantages worth exploring prior to deciding how a product is to be packaged for clinical studies or commercial distribution. This technique further enhances the benefits of prefilled syringes. Prefilled syringes vs. vials have become the container of choice for parenteral drug delivery. The increase in their use is directly ...

ABC Laboratories	Determination of Extractable and Leachable Formaldehyde in Hydroxypropyl ... Common literature methods for determining formalde- hyde in air and water are based on derivatizing formalde- hyde first, by the use of either 2,4-dinitrophenylhydrazine (DNPH) or 2,3,4,5,6-pentafluorobenzyloxyamine (PFBOA) and then quantitating the resulting hydrazone or oxime. We report general procedures for the derivatization and determination of total extractable formaldehyde as well as ...

Drug Delivery Video

Hamilton Robotics	Nano Pipettor Video on the Nanopipettor: 100 nl dispens on the fly raster: 1536

Hamilton Robotics	Nimbus The MICROLAB® NIMBUS is Hamilton Company's newest automated multi-channel pipetting platform, offering a high density deck layout in a body small enough ...

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