ISPE

JULY 5, 2023

13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter. In addition to the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have also approved applications with CM for the production of solid oral dosage forms.

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Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

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Pharmaceutical Technology

JANUARY 22, 2023

Furthermore, results show that stronger treatment efficacy correlates with higher dosages of the drug, and all patients in the highest dosage group had an adverse event. The FDA will weigh the concerns and benefits of this drug before its PDUFA date in October.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Pharmaceutical Technology

MARCH 7, 2023

There are also outside variables that can affect the flow of powders, requiring specific dosage methods to achieve the desired result. The flow and/or the dosage of the product will impact the particle size distribution (PSD) curve of the milled product, as well as the temperature of the product.

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Pharmaceutical Technology

JANUARY 6, 2023

At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug. The court filing showed that the patent details a daily administration of 0.5mg Gilenya.

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Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Simplifying technology and site transfer.

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Pharmaceutical Technology

FEBRUARY 21, 2023

For Skyepharma, a CDMO specialising in oral solid dosage forms, notable reductions in costly product waste was one advantage. Beyond the obvious benefit of freeing up the industrial press for commercial manufacturing, this can lead to several cost savings. On an industrial press, this would have been 204kg.

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Pharmaceutical Technology

DECEMBER 6, 2022

Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”. “The drugs we had 30 to 50 years ago do not even pass the minimum standard of acceptable drugs these days because they are not efficient enough to be seen of value,” says Villa.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Compared to other dosage forms, tablets are simpler to manufacture, package, and transport. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated.

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