in-PharmaTechnologist.com’s latest round up of developments in drug delivery includes Critical Pharmaceuticals’ sustained release hGH, Phase III results for AP Pharma and nanodiamonds.
Critical’s sustained release hGH
UK-based Critical Pharmaceuticals has successfully completed preclinical trials of a sustained release formulation of somatropin, a synthetic human growth hormone (hGH).
The trials found that therapeutic plasma concentrations were achieved over an extended period of time, supporting Critical’s desire to create a once every two weekly injection. Efficacy was also found to be comparable to current daily formulations.
CriticalMix technology was used to formulate the delivery system by enabling the optimal encapsulation of drugs into injectable microparticles with superior drug release properties.
The company now intends to move the product into Phase I and is considering forming a partnership to do so. Preclinical development of sustained release Risperidone and a once-daily nasal formulation of hGH is also underway.
AP Pharma posts Phase III results
AP Pharma has achieved positive results in its Phase III study comparing the efficacy of APF530 with Aloxi for the prevention of chemotherapy induced nausea and vomiting (CINV).
APF530 has been developed to prevent acute and delayed onset CINV in patients receiving moderately or highly emetogenic chemotherapy. It is delivered by a single subcutaneous injection and contains the 5HT3 antagonist granisetron and is intended to provide therapeutic relief over a five day period.
The Phase III trial included 1,395 patients and was conducted at 103 centres across the United States, Poland and India.
Nanodiamond microfilm for chemotherapy delivery
A research team has developed a nanomaterial-based biomedical device that has potential in the delivery of chemotherapy drugs.
The flexible microfilm could be implanted to sites where cancerous tumors have been surgically removed and provide a sustained release of a chemotherapeutic agent.
By releasing the chemotherapeutic agent locally the device has the potential to reduce the harmful side effects associated with such treatments.
Researchers put millions of tiny drug-carrying nanodiamonds into parylene, an FDA-approved polymer.
The nanodiamonds can be loaded with a substantial amount of a drug, in this case doxorubicin, and release it consistently over a period of time. In addition, nanodiamonds are have already been mass-produced as lubrication components, meaning the device should be economical to produce.
Parylene can be developed into very thin sheets, creating the possibility of a minimally invasive drug delivery device. Preclinical trials are now underway.