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Saint-Sauveur-en-Rue, France

Coppola M.,ESPCI ParisTech | Djabourov M.,ESPCI ParisTech | Ferrand M.,Capsugel
Polymer | Year: 2012

Plasticizing effects of water and glycerol are widely used in pharmaceutical applications of gelatin films. We investigated gelatin films containing water or water and glycerol equilibrated under a range of relative humidity. Films were characterized by differential scanning calorimetry running in classical and modulated modes. Glass and melting transition temperatures, relaxation and melting enthalpies and heat capacity changes were determined versus film composition and maturation time. This investigation quantifies the amount of collagen type structure through the melting enthalpy of triple helices. A unified phase diagram for glass and melting transition temperatures is presented as a universal curve for any proportion of water and glycerol in films versus a single parameter, which is the ratio of hydroxyl groups belonging to water or glycerol per amino-acid group and highlights the role played by the hydrogen bonding. The molecular mechanisms involved in the plasticizing effects are discussed. © 2012 Elsevier Ltd. All rights reserved.

Stegemann S.,Capsugel | Baeyens J.-P.,EUGMS | Cerreta F.,European Medicines Agency | Chanie E.,Merck Serono | And 4 more authors.
European Geriatric Medicine | Year: 2012

Non-adherence to a drug therapy is often the reason for not achieving the therapeutic goals in patients. Measuring drug adherence is an important intervention to understand patients' adherence patterns and behavior as well as to provide supportive measures to enhance the patient adherence to a prescribed drug therapy. A variety of different adherence measurement systems (AMS) exist that have been proven valid even though there is not one single AMS considered to be a gold standard. Some AMS allow through interactions with the physician or pharmacist and the patient to initiate corrective interventions, mainly in the form of alert and reminder systems. When applied to patients with several morbidities, co-morbidities and disabilities, appropriate AMS still remain a challenge. © 2012 Elsevier Masson SAS and European Union Geriatric Medicine Society. All rights reserved.

The age appropriateness of a pharmaceutical product for older patient populations is most important in achieving ease of use, administration, and adherence as well as the therapeutic benefit of the drug. Drug development is a lengthy and risky investment accompanied by extensive regulatory requirements to meet all the safety, efficacy, and quality criteria of a pharmaceutical product. Older adults represent a very heterogeneous patient population with different needs compared to younger adults. Major areas that should be considered in the design of age-appropriate products (AAP) are age-and disease-related aspects such as (a) different dose strengths, (b) issues in handling, administering, and managing the drug product, (c) and complex medication regimens. The application of different technologies can meet these specific needs and should be considered at the very beginning of product development when setting the targeted quality product profile (TQPP) or later on during the product life-cycle management. © Springer-Verlag 2012.

Stegemann S.,Capsugel | Ecker F.,FH Fulda | Maio M.,Merck Serono | Kraahs P.,Losan Pharma GmbH | And 6 more authors.
Ageing Research Reviews | Year: 2010

Demographic evolution will considerably increase the number of people aged 65 years and beyond in the coming decades. The elderly not only represent the most heterogeneous population, but also are a major user group for prescribed medicines, a predominance that will continue to further increase. Medicines and medication management are much more complex and challenging in the elderly and can only be addressed through a multidisciplinary approach.There is strong evidence that the elderly are able to properly manage their medication; however, their medications require different features than the standard medications used by adults. The elderly are exposed to several chronic disease conditions and their treatments, as well as experience age-related changes and limitations that need to be reflected in their medication management strategies.Geriatric drug therapy remains a multidisciplinary task. The health care industry, physicians, pharmacists, nurses and care givers provide and guide the patient's therapy according to individual needs, while the health care system and regulatory authorities build the necessary framework of support and resources.Any realistic and significant enhancement to the elderly patients' medicines and medication management needs to be addressed by all disciplines and stakeholders involved since the absence of any of the stakeholders in the overall process negatively impacts the achievable enhancement in geriatric drug therapy. © 2010 Elsevier B.V.

Stegemann S.,Capsugel | Connolly P.,Glaxosmithkline | Matthews W.,Glaxosmithkline | Barnett R.,Glaxosmithkline | And 5 more authors.
AAPS PharmSciTech | Year: 2014

Understanding the product and process variable on the final product performance is an essential part of the quality-by-design (QbD) principles in pharmaceutical development. The hard capsule is an established pharmaceutical dosage form used worldwide in development and manufacturing. The empty hard capsules are supplied as an excipient that is filled by pharmaceutical manufacturers with a variety of different formulations and products. To understand the potential variations of the empty hard capsules as an input parameter and its potential impact on the finished product quality, a study was performed investigating the critical quality parameters within and in between different batches of empty hard gelatin capsules. The variability of the hard capsules showed high consistency within the specification of the critical quality parameters. This also accounts for the disintegration times, when automatic endpoint detection was used. Based on these data, hard capsules can be considered as a suitable excipient for product development using QbD principles. © 2014 American Association of Pharmaceutical Scientists.

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