Alternative Drug Delivery Systems

The fast-changing health care industry is driving the development of alternative drug delivery systems. The driving factors are pharmaceutical companies' needs to extend the commercial life of patented drugs, the need by physicians to improve treatment, and benefits to patients by providing easier means for drug treatment.

SRI understands these market forces and offers biopharmaceutical companies a unique resource for the development of technology and alternative drug delivery systems. We combine our multidisciplinary approach, including chemistry, materials and engineering, with our core competencies in life sciences, including drug formulation and regulatory affairs to help companies meet their product development objectives.

Alternative Drug Delivery Systems

Dura Pharmaceuticals took on the challenge to gain market leadership for pulmonary drug delivery with a device not powered by CFCs, which will be banned in a few years. Dura realized that its in-house staff did not have the required skills and core competencies to develop the necessary manufacturing processes and bring a device to market. Dura decided to strategically align itself with SRI because of its broad science and engineering skills. Working with Dura, SRI developed a "Dryhaler" device that met all the market needs and included many features that make it easy to operate. In addition, SRI's experience and regulatory affairs expertise enabled the project to move from product concept to clinical trials in 18 months – considerably faster than the average in this medical device sector.

Oral Geriatrics/Pediatrics Drug Delivery

Alza Corporation needed to evaluate a drug delivery concept, with an emphasis on failure modes and manufacturing cost reductions. Alza looked to SRI because of its experience in drug formulation and drug delivery systems design. SRI identified key design changes that addressed the areas of concern, and added features and intrinsic value to the device while reducing its production cost. SRI demonstrated the critical manufacturing processes and delivered prototypes for marketing purposes.

Automated Syringe-filling System

A major pharmaceutical company felt its market leadership for insulin drug delivery threatened by an emerging European insulin drug delivery device. The company tapped SRI's drug delivery system expertise to develop a compact, home device for diabetics that would help them fill their insulin syringes accurately. The system needed to handle both long- and fast-acting insulin formulations and needed to be easy to use and reliable for elderly and vision-impaired patients. SRI used its industrial design expertise, along with its engineering and product development expertise, to develop an automated system that stored both types of insulin, automatically resuspended the long-acting insulin, checked for adequate drug supply, dispensed the proper amount, and kept a dosage record. The system is under test and evaluation by the client.

Disposable Drug Infusion Pump
A medical devices and pharmaceutical company turned to SRI when it needed to design a prototype disposable drug infusion pump that it had under development. The prototype used the client's proprietary power technology but was difficult to operate and too complex to manufacture. The client looked to SRI for its expertise in design for manufacturing, medical technologies, and design of medical devices, to handle the reengineering. SRI worked closely with the client's clinical and engineering team to develop a design that reduced the number of parts by 30% (27 to 17), reduced cost, and that enabled the company to scale-up its production.

Needleless Powder Injection Drug Delivery
SRI designed and laid out specifications on a manufacturing method for a drug containing cassette which greatly simplfies the process by using die-cut polycarbonate film sheets. This process was thoroughly tested and validated, and the GMP documentation was delivered to the client. SRI also identified GMP qualified manufacturers for Clinical Trials Production.

SRI also developed techniques for batch filling and sealing, and also developed a semi-automated filling system.