A new study of the potency and stability of liquid formulations of levothyroxine is being presented at the Pediatric Endocrine Society (PES) Annual Meeting.
This study adds to previously published data and questions the stability and potency of extemporaneously "compounded" liquid levothyroxine formulations by comparing and analyzing the stability and potency of a novel liquid levothyroxine formulation, Tirosint-SOL, which is packaged in patented precise monodose ampules.
The new study was conducted by researchers at the Campbell University College of Pharmacy & Health Sciences. It examined the potency and consistency of Tirosint-SOL marketed by IBSA Pharma Inc. of Parsippany, NJ using the same methodology as the previous study to determine the degree to which the product maintains its labeled potency over a five-week period. Dr. Charles Carter of Campbell University is presenting the new findings at this year's PES meeting which will be held virtually.
Results of the new study demonstrate that unlike extemporaneously compounded formulations of liquid levothyroxine, which are packaged in a variety of containers, new Tirosint-SOL demonstrated consistent and predictable product potency, an important consideration for clinicians prescribing levothyroxine.
"Levothyroxine is a narrow therapeutic index (NTI) drug with potentially deleterious patient outcomes if administered in sub or supratherapeutic doses", said Dr. Carter. "The inconsistent product potency exhibited by compounded formulations should be of great concern to clinicians, patients and public health officials. By comparison, our new study shows that a novel formulation of levothyroxine liquid, Tirosint-SOL packaged in a unique monodose ampule demonstrated consistent and predictable levels of potency and stability."
The study was sponsored by IBSA Pharma Inc., makers of Tirosint®-SOL (levothyroxine sodium) oral solution. Tirosint-SOL is the only FDA-approved liquid levothyroxine formulation available in monodose packaging for convenience and dosing precision. It is approved for treating hypothyroidism among patients of all ages and is made with only levothyroxine, glycerol and water for enhanced tolerability and absorption. Tirosint-SOL is available in 12 dosage strengths and may be administered by squeezing the contents of the monodose ampule directly into the mouth, using a spoon or mixing the drug in water. Additional information, including money-saving options for patients that may reduce the cost of Tirosint-SOL to as little as $25 per month can be found at www.TirosintSOL.com. The Tirosint Direct Program provides patients with another savings option for obtaining their prescribed therapy. Through the Tirosint Direct program, patients can access a network of mail order pharmacies providing Tirosint-SOL for as little as $40 per month regardless of their insurance coverage. Go to www.TirosintSOL.com for more details.
Hypothyroidism is an endocrine disorder with numerous causes resulting in a deficiency in thyroid hormone. More than 27 million adults have been diagnosed with hypothyroidism. ¹ Up to 13 million Americans have undiagnosed hypothyroidism. ² About 2% of the U.S. population has pronounced hypothyroidism, and as much as 10% has subclinical (mild) hypothyroidism. The condition is most common in women over 40 years of age and in the elderly of both sexes.³ The signs and symptoms of hypothyroidism are nonspecific and may include fatigue, forgetfulness, depression, constipation, muscle cramps, weight gain, dry skin and hair loss.⁴ Laboratory tests (TSH, FT3 and FT4) are the most common biochemical parameters used in diagnosing hypothyroidism.⁵ Levothyroxine sodium is a synthetic version of a hormone that is normally produced by the thyroid gland. It is used to treat patients who suffer from hypothyroidism or inadequate levels of thyroid stimulating hormone (TSH).