International journal of pharmaceutics
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Drug counterfeiting detection is very important for the safety of patients around the world. Counterfeit pharmaceutical products can be referred to the production and distribution of mislabeled medications in which the identity, authenticity, and/or effectiveness is altered. Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. ⋯ Certain counterfeit detection devices have been successfully used for qualitative and quantitative assessment to differentiate counterfeit medications from the reference product. Different technologies are needed to identify the chemical properties of a questioned drug product, which can then be used to determine its authenticity. This review examines the implications of counterfeit medications and the current technological approaches that are able to detect counterfeited pharmaceuticals.
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Drug counterfeiting detection is very important for the safety of patients around the world. Counterfeit pharmaceutical products can be referred to the production and distribution of mislabeled medications in which the identity, authenticity, and/or effectiveness is altered. Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. ⋯ Certain counterfeit detection devices have been successfully used for qualitative and quantitative assessment to differentiate counterfeit medications from the reference product. Different technologies are needed to identify the chemical properties of a questioned drug product, which can then be used to determine its authenticity. This review examines the implications of counterfeit medications and the current technological approaches that are able to detect counterfeited pharmaceuticals.
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Drug delivery via the inhaled route has advantages for treating local and systemic diseases. Pulmonary drug delivery may have potential in treating tuberculosis (TB), which is mainly localised in the lung (pulmonary tuberculosis ∼75%) while also affecting other organs (extra-pulmonary tuberculosis). Currently, rifampicin, a first-line anti-tubercular drug, is given orally and the maximum daily oral dose is the lesser of 10 mg/kg or 600 mg. ⋯ Pulmonary delivery of rifampicin, either alone or in addition to the standard oral dose, has the potential to achieve a high concentration of rifampicin in the lung at a relatively low administered dose that is sufficient to kill bacteria and reduce the development of drug resistance. As yet, no clinical study in humans has reported the pharmacokinetics or the efficacy of pulmonary delivery of rifampicin for TB. This review discusses the opportunities and challenges of rifampicin delivery via the inhaled route and important considerations for future clinical studies on high dose inhaled rifampicin are illustrated.
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Recent years have seen a marked diversification of excipient based formulation strategies used for the development and commercialisation of dry powder inhaler (DPI) products. These innovative approaches not only provide benefits to patients and health care professionals through the availability of a wider range of therapeutic DPI products, but, importantly, also allow formulators to exploit the potential opportunities that excipients provide for the development of DPIs. Whilst many DPI products have, and continue to be developed using a single formulation excipient, the commercialisation of DPI products which contain the two excipients lactose monohydrate and magnesium stearate, namely the 'dual excipient platform' has recently been achieved. This article provides an overview of the background and current status of the development of such 'dual excipient platform' based DPI products.
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Review
Progress review of the European Paediatric Regulatory Framework after six years of implementation.
The EU regulation (EU 1901/2006 Paediatric Regulation) that entered into force in 2007 has changed the field of medicinal drug development for children in the EU. Five years after its implementation a large number changes due to this regulation have been incorporated by Pharmaceutical Industry considering the development of new candidate drug. This report is a review of changes already implemented and the aspects of paediatric drug development, which still needs to be addressed in future working in the fields to provide better medicines for children.