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Equipment and Processing Report
Capacity expansions and new products meet needs for inhaler and injector systems.
The North American market for drug-delivery technologies is projected to grow 8.9% per year through 2017, according to a report published by MarketsandMarkets (1). With such a positive forecast, it’s not surprising there is a constant flow of drug-delivery innovations involving metered-dose inhalers, needle-free injectors, autoinjectors, nasal sprays, transdermal patches, nebulizers, infusion pumps, drug-eluting stents, sustained-release formulations, ocular implants, and related packaging. Interest is particularly strong for dry powder inhalers, needle-free injectors, auto and pen injectors, orodispersible tablets, transdermal patches, and buccal transmucosal tablets, notes the report.
Suppliers are boosting capacity to meet rising demand in North America and around the world. In January 2013, Catalent Pharma Solutions announced a $20-million investment in its Inhalation Center of Excellence in Research Triangle Park, NC. The project will expand production capabilities for clinical and commercial pressurized metered-dose inhalers.
SHL Group (Sweden) is spending $40 million to expand production of autoinjectors and pen injectors in Taiwan. “Our customers are bringing more biologics to market,” explained Roger Samuelsson, chief executive officer of SHL, in a press release (2). SHL’s injector product range includes disposable and reusable devices with fixed or variable dosing, enhanced precision, and the ability to accommodate high-viscosity liquids. SHL also makes inhaler systems.
The need to accommodate biologics with higher viscosities and patients with limited dexterity prompted Unilife to develop the Unifill Assure injector. An extended finger flange with a soft, rubberized, non-slip grip and an easy-to-press thumb button on a strengthened plunger improve ergonomics. Compatible with standard fill/finish lines, features include automatic user-controlled needle retraction. The automatic needle retraction eliminates the need for ancillary needle sheath-based safety products, ensures patients have an unobstructed view of the drug from any angle during all stages of use, reduces the risk of needlestick injuries or the aerosolization (splatter) of blood or tissue residue, and helps minimize the size of the injector and waste disposal requirements. Audible, tactile, and visual indicators simultaneously confirm full-dose delivery and activation of the retraction mechanism. After retraction the plunger locks preventing reuse or needle re-exposure.
Ease of use is an important attribute for virtually all drug-delivery segments. For inhalation products, Aptar Pharma Prescription Division has developed the simple-to-use, easy-to-clean Twister dry-powder inhaler. Introduced at Pharmapack Europe, Feb. 13-14, 2013, in Paris, France, and also displayed at Pharmapack North America, June 18-19, 2013, in Philadelphia, the design improves access to medication as well as patient compliance. Molded and assembled in a class ISO 7 cleanroom at the company’s production facility in Suzhou, China, the device is suitable for early-phase clinical trials and for medication that treats asthma and chronic obstructive pulmonary disease. It works in three steps: insert, twist, and inhale. The twisting action crushes a capsule to release the drug. Patients can observe the processing of the capsule and powder through the transparent container and also receive audible and visual feedback confirming that the full dose has been properly delivered.
—Hallie Forcinio is Pharmaceutical Technology's packaging editor, email@example.com.