A.P. Pharma has made significant investments in the development of its bioerodible drug delivery technologies, which have produced tangible results. Specifically, the Company has developed a broad family of polymers with unique attributes, known collectively as poly(ortho esters), under the trade name Biochronomer. This technology has been specifically designed for use in drug delivery applications with a number of technical advantages, such as ease of manufacturing, flexible delivery times, various physical forms and multiple potential applications due to a neutral pH environment for acid sensitive actives (nucleic acids, proteins, etc.).
Due to the versatility of the Company’s Biochronomer technology, products can be designed to deliver drugs at a variety of implantation sites including under the skin, at the site of a surgical procedure, in joints, in the eye or in muscle tissue. The Biochronomer technology can provide sustained levels of drugs in systemic circulation for prolonged efficacy.
Ease of Manufacturing
A.P. Pharma’s Biochronomer technology is formed by the coupling of various monomers into a polymer chain. The Company’s process knowledge underlying the commercial manufacture of its Biochronomers is based on extensive, well-documented development studies. Commercial manufacturing campaigns to date have demonstrated that A.P. Pharma’s Biochronomers may be produced in a highly reproducible manner.
Flexible Delivery Times
The Biochronomer “links,” or bonds, are stable at neutral pH conditions. Upon coming into contact with water-containing media, such as internal body fluids, the water reacts with these bonds. This reaction is known as hydrolysis. During the hydrolysis of the Biochronomer links, acidic elements are produced in a local micro-environment, in a controlled manner, without impacting the overall neutrality of the drug delivery technology. These elements assist in the continued, controlled erosion of the polymer with a simultaneous, controlled release of the active drug contained within the Biochronomer. By varying the amount of the acidic elements in the Biochronomer, different rates of hydrolysis may be effectively realized. In this manner, delivery times ranging from days to several months can be achieved.
Various Physical Forms
The Company’s Biochronomers can be prepared in a variety of physical forms, ranging from hard, glassy materials to semi-solids that are injectable at room temperature, by proper selection of monomers. A significant advantage of A.P. Pharma’s Biochronomer technology is that drugs can be incorporated by simple mixing procedures allowing the production of formulations in the form of injectable gels, microspheres, coatings and strands. All of these physical forms can be used in the controlled delivery of drugs without the undesirable incorporation of organic solvents in the final product.
Multiple Potential Applications
A.P. Pharma has completed over 100 in vivo and in vitro studies demonstrating that its Biochronomer technology is potentially applicable to a range of therapeutic areas, including pain management, prevention of nausea, control of inflammation and treatment of ophthalmic diseases. The Company has also completed comprehensive animal and human toxicology studies that have established that its Biochronomer polymers are well tolerated.
Strong Patent Portfolio
The Company’s patent portfolio includes a total of 20 issued U.S. patents and an additional 54 issued (or registered) foreign patents.