Formulation and Drug Delivery, Combination Drugs

The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.

The two companies signed an exclusive collaboration agreement for the Aidaptus auto-injector.

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

Bi-layer tablets are an under-utilized option that can be employed to help reduce treatment burden, but their formulation is more complex than for conventional monolayer products.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

Empty and prefilled syringes must pass a range of quality control tests.

Using training devices may ease patient anxiety about using autoinjectors and prefilled syringes, potentially leading to improved patient adherence.

FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.

Pharmaceutical companies are developing new strategies to address the ever-increasing development costs for new drug therapies and maximize the value of their existing drug portfolio.

Formulation characteristics must be optimized, following device selection, to achieve the desired performance for the capsule loaded in the dry powder inhaler.

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

Medherant has developed an improved instrument for testing drug release from transdermal patches.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

The authors discuss regulatory and patent issues with combination products.

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.

Adocia has reported positive results for the first clinical trial of its combination insulin formulation of fast- and long-acting insulin in patients with type I diabetes. Results showed that BioChaperone Combo provided both short- and long-term control of blood glucose in type I diabetic patients, with a faster onset and a longer duration of action.

Researchers at Massachusetts recently reported on the development of a drug-eluting contact lens designed to provide prolonged delivery of the glaucoma medication, latanoprost.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.

Abuse-deterrent combination drugs represent a niche area in formulation development.

One particularly crucial parameter for nasal sprays is the size of the droplets produced during actuation, which can potentially impact bioavailability.

The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register.

Combination products have been researched and administered for many years, some successfully and others not.

Combining drugs with synergistic mechanisms of action yields some indisputable benefits; improved efficacy, reduced dosing, enhanced patient compliance, to name just a few.