parenterals

Hospira Announces Recall On Over Fill Issue

Hospira, Inc. announced today it is initiating a nationwide, voluntary, user-level recall of one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1 mL labeled fill volume.
 
Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed.

Promoting Patient Safety through Product Quality

Deck: 
At Pharmapack Europe, next-generation packaging technology seeks to address drug makers’ concerns about contamination.

Speakers and exhibitors at Pharmapack Europe February 15-16 will be focusing on easing drug delivery while overcoming industry’s challenges.

Can’t Make It to Europe?

Reconstructing Reconstitution

Building on a long history of reconstitution, two companies devise a new system for sterile water for injection intended to promote ease of use and dosing.
By Mike Schaefers, West Pharmaceutical Services; and Thomas Otto, Vetter
The process of freeze-drying injectable drugs by removing water from the material and sealing the material in a vial, known as lyophilization, was developed in the mid 1930s. Since then, lyophilization has created a faster and more convenient path for many new drugs, including biologics, to reach the market.
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JHP Pharma Announces Chief Executive Officer Succession

JHP Pharmaceuticals announced that Stuart Hinchen would succeed Peter Jenkins as Chief Executive Officer of the company effective July 1, 2011.

Vetter Invests in Additional Lyophilization Capacity

Vetter has installed three additional state-of-the-art lyophilizers at the company’s Ravensburg, Germany Vetter South facility, nearly doubling its number of freeze-dryers. Altogether, the site will be able to produce up to 24 million lyophilized units annually, the company said in a press release.
 
The new equipment increases the number of lyophilizers across all Vetter facilities by 30 percent.

The Latest in Drug Delivery and Parenteral Packaging

Drug-Delivery Devices
A supplier of noninvasive drug-delivery devices has launched a new Web site to aid in the identification and selection of spray, aerosol, or dispensing systems. Visitors can select a particular application field or therapy, such as Nasal Decongestant or Asthma. The company offers customized solutions, technical and scientific support, formulation science, testing and analytical laboratories, regulatory support, elastomer development and filling and packaging, for research and development purposes. Aptar Pharma, www.aptar.com/pharma.

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West Plastic Syringe With Prefixed Needle Targets Biologics

West (www.westpharma.com) has expanded its family of cyclic olefin polymer (COP) products with the introduction of the Daikyo Crystal Zenith (CZ) 1-mL long insert needle syringe system. The 1-mL long format has been favored for packaging of biologics in prefilled syringes. In manufacturing at West’s Scottsdale, AZ, facility, the needle is insert-molded into the plastic syringe.

dhesives and tungsten residues—potential contaminates in glass syringes with staked needles—are avoided, says Graham Reynolds, vice president, marketing and innovation, West.

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Comfort In Parenteral Delivery

Automated device functions and safety features make parenteral administration less onerous for self-treating patients.

Advanced parenteral delivery solutions are affording product differentiation and therapeutic benefits across a range of therapies.

In needle-based injection, cartridge-based pens and prefilled syringes loaded into disposable auto injector devices offer features that support easier self administration by patients.

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Groups Studying Glass Vials

After a year of recalls involving what some call “glass delamination,” industry gathers to investigate.

In 2011, the Parenteral Drug Association (PDA; www.pda.org) and Rx-360 (www.rx-360.org) will be looking at some of the challenges the pharmaceutical industry has encountered with recalls associated with glass vials. Several recalls have involved the discovery of particulate matter inside the vials of injectible drugs.

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LF of America Highlighting Packaging for Medical and Pharmaceutical Applications at WestPack

LF of America Corp. (www.lfweb.us) will be on hand at WestPack 2011, February 8 – 10 at the Anaheim Convention Center in Anaheim, CA. WestPack. At Booth 5278, LF of America will be showcasing its line of medical-grade unit-dose or multi-dose containers as well as the Lameplast line of pharmaceutical containers for parenterals.

The medical-grade packages consist of strips of five containers and multi-dose wand tubes that can be customized with five different applicator tips including four different hypoallergenic silicone applicators.

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