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FDA Releases Draft Guidance on Essential Drug Delivery Outputs

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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Gelteq IPO: Supporting Gel Technology for Oral Drug Delivery

XTalks

Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements.

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Intranasal Therapeutics and Drug Delivery Systems: The Perfect Alternative to Conventional Route of Administration

Roots Analysis

Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.

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The Power of Lipids: Enhancing Drug Delivery with Nanoparticles

Roots Analysis

Over the last decade, one of the major challenges faced by pharmaceutical companies across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility.

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Scilex buys rights to acute migraine treatment Elyxyb in Canada and the US

Pharmaceutical Technology

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

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Nanoparticle Formulation: A Paradigm Shift towards Novel Drug Delivery

Roots Analysis

Owing to their unique size and physicochemical properties ( surface roughness, surface area, surface energy, crystal structure and shape ), nanoparticles can be widely used as a contrasting agent in medical imaging, a vesicle to cross the blood-brain barrier and a carrier for targeted delivery of genes / drugs, proteins, vaccines and antibiotics.

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Pharmanovia taps Nanoform to improve bioavailability of ‘iconic branded medicine’

Outsourcing Pharma

The pharmaceutical company has forged a partnership with the nanotechnology specialist to use nanoparticle tech and formulation to advance its products.