News & Blog
Posted in Press Releases | 10.10.13
Punta Gorda, FL – PharmaCaribe’s PulmoSal™ 7% (pH+)™ (sterile sodium chloride inhalation solution 7%, pH 7.4) received FDA Clearance for commercialization on March 13, 2013 and will be available by prescription from Cystic Fibrosis Services, A Walgreens Alliance Pharmacy on December 1, 2013, and from other pharmacies shortly thereafter. PulmoSal™ 7% (pH+)™ is the first and only FDA-cleared buffered formulation of 7% saline solution for inhalation.
According to W. Randolph Warner, a Managing Member of PharmaCaribe, the concept for developing a buffered saline solution for inhalation that matches the normal pH (pH of 7.3-7.5) of the airway surface liquid (ASL) of the lungs came from several studies including a study presented at the 2012 North American Cystic Fibrosis Conference (NACFC) pointing out that the innate immune system works best if the pH of ASL is at its homeostatic level of 7.4 +/-. The question was why couldn’t we have hypertonic saline solution inhalation treatments that would not add acidity to a typically acidic environment but provide hypertonic saline at a homeostatic pH?
In addition, Mr. Werner Gutmann, COO, of PharmaCaribe stated that, “Today, all commercially available 7% sodium chloride solutions for inhalation are manufactured in accordance with the United States Pharmacopeia (USP) guidelines that allow for a pH of between 4.5 to 7.0. The National Institute of Health defines the typical physiological pH of the human lung 7.38-7.42 (average 7.4). Furthermore, all of the 7% saline solutions for inhalation that are currently available are acidic, with pH values averaging 6.2”
Now physicians have a choice when prescribing 7% hypertonic saline either as an Rx for an acidic solution or for a non-acidic solution like PulmoSal™ 7% (pH+)™ where they know the exact pH of the solution their patients are receiving.
PharmaCaribe’s Bio-Balanced™ PulmoSal™ 7% (pH+)™ is a unique, patent pending formulation of hypertonic saline, buffered with sodium bicarbonate to a slightly alkaline pH of 7.4 that matches the normal pH of the ASL. Preston W. Campbell, III, M.D., executive vice president for medical affairs at the Cystic Fibrosis Foundation said, “We believe that
PharmaCaribe has taken the right approach with their second generation hypertonic saline product by buffering the solution with sodium bicarbonate.
About PharmaCaribe, LLC:
Pharmacaribe is a leading manufacturer of saline solutions for inhalation and has worked
collaboratively with the Cystic Fibrosis Foundation and Cystic Fibrosis Services, Inc. to bring new and novel products to the cystic fibrosis community.
PharmaCaribe, LLC is a privately held company headquartered in Punta Gorda, FL.
For more information please contact Werner Gutmann, COO and Managing Member of
PharmaCaribe at 804-339-4523 or [email protected].