Excipients in formulations for clinical trials: Getting it right the first time [PDF]
, 2011 An ignorant and therefore, nonchalant and indifferent attitude, bordering on the cavalier, toward excipients as potential enablers for drug delivery, creates a hubris in the early stages of the drug development process that serves to dismiss the pivotal ...
Apte, Shireesh, Shireesh Apte
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British Journal of Clinical Pharmacology, EarlyView.Abstract Aim Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.
Anna Lundahl +14 more
wiley +1 more source
Lipids in pharmaceutical and cosmetic preparations
Grasas y Aceites, 2000 In this paper, a review of the applications of lipids in the pharmaceutical field has been reported. In a first stage, different lipids used as excipients in cosmetics and medicines have been described.
Antonio M. Rabasco Alvarez +1 more
doaj +1 more source
Functionality specific excipients influencing manufacturability and/or processing of pharmaceutical dosage forms: a wish list [PDF]
The non-availability of suitable excipients that perform specific functions in manufacturing unit operations or during storage leads to suboptimal processes and formulations.
Shireesh Apte
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The regulation of Pharmaceutical Excipients [PDF]
, 2013 Pharmaceutical excipients are vital components of a dosage form, but these so called inactive ingredients are considered somewhat inert when compared with active pharmaceutical ingredients.
sekhon, Bhupinder singh, Saluja, Vikrant
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Development of a nalmefene formulation suitable for a community‐use auto‐injector
British Journal of Clinical Pharmacology, EarlyView.Aim Time to onset of reversal is critical when treating opioid‐induced respiratory depression and hypoxia. This study aimed to develop a formulation of the opioid antagonist nalmefene with an increased absorption rate and reduced time to onset of reversal following intramuscular administration. Methods Several absorption enhancers were screened in rats,
Alessandra Cipriano +6 more
wiley +1 more source
Expanding innovation in the field of pharmaceutical excipients [PDF]
, 2012 The current generation of combined or derivatized excipients (from food products) primarily increase manufacturing efficiencies, improve API ADME profiles and provide sustained delivery.
Apte, Shireesh, Shireesh Apte
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The impact of medication shortages on paediatric care: A retrospective impact analysis
British Journal of Clinical Pharmacology, EarlyView.Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg +6 more
wiley +1 more source
Manufacturing techniques and excipients used during the formulation of oil-in-water type nanosized emulsions for medical applications [PDF]
, 2016 Medically, the oil-in-water nanosized emulsions are used mainly as delivery carriers for lipophilic drug molecules which show therapeutic activity when administered via parenteral, ocular and transdermal routes. To extract multifunctional activities, the
Shunmugaperumal Tamilvanan +3 more
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A shotgun approach to identifying immune evading excipients for biologics drugs [PDF]
, 2023 Not ...
Shireesh P Apte
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