Formulation and Drug Delivery, Topical Drugs

API permeation into the skin modulates the efficacy of topical treatments.

Ongoing advances in technology and modeling techniques are helping to align all the objectives of both drug manufacturers and patients.

MedPharm’s new facility for process development and small-scale manufacturing is in North Carolina, near its existing R&D center.

Study results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

Virpax’s Patch-in-a-Can technology delivers pain medication using a metered-dose spray film.

Medherant has announced positive results from two Phase I trials evaluating its transdermal drug delivery patch loaded with ibuprofen.

Funding from Innovate UK will be used by Medherant to support manufacture of transdermal patches for clinical trials.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

The human skin protects the body from physical, mechanical, and chemical insults while preventing endogenous water loss. This function is predominantly achieved by a thin (10–30 µm) cornified outermost layer-the stratum corneum (SC)-generated through terminal differentiation of the basal epidermal keratinocytes. The stratum corneum protects the human body, but also severely limits drug delivery into and across the skin.

Drugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.

The contract development and manufacturing organization will discuss its capabilities in topical drug products at CPhI North America, taking place April 24–26, 2018 in Philadelphia, PA.

MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage.

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

The authors of the study believe it could have significant implications for the discovery of new dermatological products for major diseases such as psoriasis.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Sienna Biopharmaceuticals has filed for an IPO, expecting to raise over $74 million

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

Tapemark, a full-service CDMO specializing in transdermal, oral thin film, and topical drug-delivery technologies, is exhibiting at CPhI.

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.

Topical semi-solids, like creams, lotions and ointments are comprised of a complex mixture of microstructures or colloidal phases, frequently referred to as the Q3. These microstructures may include micelles, lamellar phases, polymer matrices, liquid crystalline and crystalline states of wax excipients, as well as the solid states of active pharmaceutical ingredients. Different topical medicated semi-solid formulations, spanning a range of treatment indications, reveal a variety of different microstructures.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.