Companies Launch Formulation and Drug-Delivery Services at AAPS

Atlanta (Nov. 17)-Companies at the American Association of Pharmaceutical Scieintists (AAPS) unveiled technologies, expansion plans, and services for formulation development, manufacturing, and drug delivery at the AAPS Annual Meeting and Exposition held in Atlanta last week.

Advion BioSystems (Ithaca, NY) and Agilent Technologies (Santa Clara, CA) formed a nonexclusive comarketing agreement to copromote the Advion “TriVersa NanoMate” system with Agilent mass spectrometers. The TriVersa NanoMate is an automated fraction collection and nanoelectrospray system that connects to the inlet of a mass spectrometer. It combines the benefits of micro- or capillary-scale liquid chromatography (LC), with simultaneous fraction collection and subsequent chip-based infusion of the LC fractions in one system to increase the performance and automation of a mass spectrometer.

Azopharma’s (Hollywood, FL) Product Development Group is adding new laboratory facilities and office space in Welwyn Garden City, United Kingdom. The new facility will provide analytical, QP release testing, preformulation, and formulation development services to the European market.

BASF (Ludwigshafen, Germany) featured recently achieved excipient verification certificates from the United State Pharmacopeia (USP). BASF’s sites in Geismar, Louisiana, and Ludwigshafen, Germany, were audited and certified by USP under its new Excipient Verification Program. The certificates cover BASF’s povidone, crospovidone, and copovidone products, made at these sites. Also, PVP-iodine, a disinfectant produced at BASF’s Geismar’s facility, was also certified.

Catalent Pharma Solutions (Somerset, NJ) introduced its “Secure-Vial” technology, a new patent-pending delivery system for injectable drug products. The “Secure-Vial” system is a specially designed polypropylene vial containing a rubber stopper that is created through a blow–fill–seal manufacturing process. Blow–fill–seal is a manufacturing process by which containers are formed from plastic resin, filled with a liquid, and then sealed, all within a contained and highly automated process. Blow–fill–seal is used to manufacture sterile liquid pharmaceuticals such as ophthalmic and nebulized respiratory products, and the company notes that its potential is becoming increasingly recognized for injectable liquid products.

CiVentiChem (Cary, NC) has expanded its research and development laboratory in Cary, North Carolina, with the launch of CiVentiAnalytical, a new analytical laboratory operating under good laboratory practices and current good manufacturing practices. In addition to the analytical chemistry laboratory in Cary, North Carolina, the company is adding a new active pharmaceutical ingredient plant and intermediates pilot plant in Hyderabad, India, to manufacture large-volume products.

Covidien’s business unit Mallinckrodt Baker (Phillipsburg, NJ), launched its “PanExcea” MC200 performance excipient for oral disintegrating tablet applications.

Dow Wolff Celulosics, a business unit of The Dow Chemical Company (Midland, MI) announced that a second drug candidate being developed by Bristol-Myers Squibb (New York) will use Dow’s “Foam Granulation Technology” in the development and manufacture of tablets for clinical and commercial use.

International Specialty Products (Wayne, NJ) expanded its “Advantia” line of coating systems with the addition of “Advantia” Preferred HS coatings. The new coatings are based on combinations of polymers and plasticizers for immediate-release film coating of oral solid dosage forms for pharmaceutical products and dietary supplements. They can be applied in up to 25% high-solid suspension.

Lancaster Laboratories (Lancaster, PA) featured its newly launched raw materials express testing program, which streamlines raw materials testing expressly for certain routine USP tests.

Metrics (Greenville, NC) will open a dedicated potent and cytotoxic drug-development facility as part of a recent $18-million expansion. The new facility has two processing rooms with independent entry double airlocks, independent decontamination shower and exit airlocks, independent equipment airlocks, and access to a dedicated washroom. Equipment and change parts are dedicated exclusively to potent and cytotoxic use, and containment is achieved at levels approximately 30 nanograms per cubic meter of room air.

Patheon (Toronto) has relaunched its alliance with Depomed (Menlo Park, CA), a specialty pharmaceutical company. The alliance unites Depomed’s proprietary “AcuForm” polymer-based delivery technology for extended release with Patheon’s manufacturing and distribution facilities. Patheon also formed an alliance with Senopsys (Saugus, MA), a specialty pharmaceutical company, to develop dose formulations that enhance palatability with improved sensory characteristics such as smell, taste, texture, mouthfeel, and appearance. The alliance will apply to pediatric formulations, line-extension products, and reformulated pharmaceutical products.
           
PharmaForm (Austin, TX), a pharmaceutical product-development manufacturing and analytical testing services company, launched its Evaporative Precipitation into Aqueous Solution (EPAS) drug-delivery technology. EPAS is a particle engineering technology that produces nanostructured parties with properties of high surface area, rapid dissolution, improved physical stability, and exceptional bioavailability, according to the company. The technology is designed to transform poorly water-soluble drugs into stable nanoparticles with physical milling or grinding procedures. EPAS can be applied to hydrophobic molecules and to a variety of dosage forms, including solid oral, liquid, pulmonary, and transdermal.

Philips Research (Amsterdam) launched its new intelligent pill technology “iPill.” The iPill is a capsule, the same size as a camera pill, and is designed to be swallowed and to pass through the digestive track naturally. It can be electronically programmed to control the delivery of medicine according to a predefined drug release profile. The iPill determines its location in the intestinal tract by measuring the local acidity of its environment. The iPill releases medicine from its drug reservoir via a microprocessor-controlled pump for programmable drug delivery. In addition, the capsule is designed to measure local temperature, and report measurements wirelessly to an external receiver unit.

Rohm and Haas (Philadelphia) launched a new service for developing oral drug formulations that brings together the company’s Advanced Release Technologies from its Ion Exchange Resin Division with its “FloVitro” dissolution test methodology. Rohm and Haas will provide services ranging from simple, initial screening studies, to the development of resinates (i.e., drug-resin complexes), supported by the FloVitro dissolution test methodology.

3M Drug Delivery Systems (St. Paul, MN) released data highlighting the tolerability and delivery characteristics of a hollow microstructured transdermal system (hMTS) for the systemic delivery of high volume injectables that are traditionally delivered by syringe and needle. The data, which showed results from both animal and human testing, was presented by Kris Hansen, technical manager for 3M Drug Delivery Systems, at a poster session at AAPS. The findings showed that deliveries of human growth hormone and naloxone via an hMTS patch were found to be comparable to a subcutaneous injection with regard to bioavailability and pharmacokinetic (PK) profile. The company said the  data showed rapid transdermal infusion of nontraditional transdermal drugs in liquid formulations, highlighting the potential of this delivery technology for relatively high volume injectables, including small-molecule salts and large molecules (up to 150 kD) traditionally delivered by intramuscular or subcutaneous injection. 3M also presented data reinforcing the efficacy of its solid microstructured transdermal system (sMTS) for delivery of vaccines as well as for systemic delivery of highly potent proteins.