The Latest in Drug Delivery and Parenterals
A manufacturer of precision airless dispensers introduces a patented actuator. The Self-Sealing Actuator suits dose dispensing of lotions, creams, gels, ointments, and emulsions. The actuator protects products from impurities and contamination through a membrane in its orifice that automatically seals once the formula has been dispensed. This prevents the product from coming into contact with oxygen, reducing contamination, discoloration, and product dry-out, and increasing shelf life and effectiveness. The actuator is available in the manufacturer’s Mezzo, Mini, Midi, and Macro models, in round or oval containers, from 30 to 200 ml. A wide range of dosage amounts are also available. Mega Pumps, Eatontown, NJ; 732/578-9100; www.megapumps.com.
Silicone Drug Delivery
A global formulator and manufacturer of silicone compounds presents its full line. Drug Delivery Silicone (DDS) materials and services are intended specifically for drug delivery and combination medical device products. DDS materials can be customized for specific applications and uniquely tailored to influence the release of a wide range of Active Pharmaceutical Ingredients (APIs). On a large or small scale, the manufacturer can incorporate APIs directly into silicones in its production-scale manufacturing site that has been registered with FDA and is ISO 9001:2000-certified. NuSil Tech-
nology, Carpinteria, CA; 805/684-8780; www.nusil.com.
An equipment provider introduces a balcony washer. The Type 308 balcony washer from BASE Europe GmbH, the company’s German manufacturer, is designed for high-speed washing of ampules, vials, and syringes. The Type 308 features a balcony design that allows the operator to maintain visual contact with the process while the separation of the cleaning and the maintenance areas improves machine access for enhanced performance and faster changeovers. It allows a stationary operator to easily see both the transport and cleaning processes, compared vial washing systems that require a walk-around to maintain visual access to the processes. Bausch Advanced Technology Group, Clinton, CT; 860/669-7380; www.bausch-group.com.
A specialist in ready-to-fill systems now produces prefillable syringes as well. The company’s subsidiaries have patented Baked-On RTF, a new process for syringe siliconization to deal with biotech injection materials sensitive to silicone oil coating on the glass wall. The company says it significantly improves the long-term stability of drugs while retaining the long-proven glide agent for the syringe plunger. The company delivers product to the pharma industry after in-house siliconization, full preassembly, and final sterilization. A syringe center is qualified to elucidate materials and technologies and weigh up conceivable alternatives in comparison with each other. Gerresheimer, Düsseldorf, Germany; +49 211 6181250, www.
A company has unveiled an innovative side-actuated device for nasal drug delivery. The side-actuated device is, according to the manufacturer, compact, ergonomically designed, and intuitive to use. The device requires moderate actuation effort, and was designed to ease self- and third-party-
administration, especially pediatric. According to the company, using the side-actuator removes axial nozzle movement inside the nostril when the actuator is pressed, eliminating risk of the nozzle entering the nostril too deeply. A level indicator allows patients to see the amount of drug left and to replace medication before it runs out. Valois Pharma France; + 33 1 39 17 20 20; www.valoispharma.com.
A ready-to-use plunger and stopper company has launched a line of sterile stoppers. The new range of sterile stoppers for antibiotic, infusion, and lyophilization vials satisfies the requirements of pharmaceutical laboratories for component quality and regulatory documentation. The sterile stoppers can be used immediately, enabling good resource distribution and removing sterilization equipment needs with all associated validations. The manufacturer says it combines high-quality components with effective validation and revalidation procedures in line with ISO standards 11137 and 11607, and documentation certifying compliance, including an FDA-registered type V DMF and a certificate guaranteeing sterility. Stelmi, Princeton, NJ; 609/452-9100; www.stelmi.com/uk.
A new polymer is available for respiratory devices and blood therapy devices. Tritan copolyester is BPA-free, has a glasslike transparency, and offers durability. The material offers lipid and chemical resistance, high heat stability, easy processing, excellent long-term clarity, added durability and toughness, according to the manufacturer. This combination allows the new material to perform at a level comparable to other polymers in the medical industry. It provides protection against the negative effects of common materials that can lead to environmental stress cracking and deterioration in medical environments. Eastman Chemical Co., Kingsport, TN; 423/229-2000; www.eastman.com/tritan.