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Pharmaceutical Manufacturing and Packing Sourcer
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| People with a visual impairment often experience problems in
differentiating packets, with the increased standardisation of
packaging sizes and shapes. They can also have problems with
reading the instructions since they are often printed in a small
typeface with poor visual quality. In order to alleviate these
problems, the European Commission has issued a directive requiring
suppliers of pharmaceutical products to incorporate braille labels
and produce information leaflets in alternative formats. However, the
associated standard has yet to be published, which leaves uncertainty
about the detailed implementation of the directive.
Packaging poses significant problems for many older people.
This is often due to an inability to read the label, understand its
meaning or open the package without damaging the contents.
Failure to take medicine correctly has been estimated to cost the
US economy $100 billion per year (1). THE VISUALLY IMPAIRED POPULATIONAbout 1.5 per cent of the population could be officially registered as
‘blind’ or ‘partially sighted’. Of these, around 0.4 per cent have to
rely on non-visual methods to access information (2)... |
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News and Press Releases |
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MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita
MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
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White Papers |
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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events |
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SAPHEX 2019
23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA
SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention
Centre, Johannesburg, South Africa.
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