New Study Confirms the Stability and Potency of a Novel Formulation of Liquid Levothyroxine

PARSIPPANY, N.J., April 30, 2021 /PRNewswire/ -- 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.

About Hypothyroidism
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).

About IBSA Pharma Inc.
IBSA Pharma Inc. is part of IBSA Group, which is headquartered in Lugano, Switzerland. The company is a world leader in the treatment of thyroid disease and has a diversified product portfolio of prescription drugs. With products on five continents and over 80 countries, IBSA has a commitment to scientific research and improving the health of patients.

References
1. IMS Institute for Healthcare Informatics Report, "Medicine Use and the Shifting Costs of Healthcare"; 2014; pg. 46 2. Booth, M, 2019. Published online at: http://www.reviewjournal.com/life/health/thyroid-disease-common-us 3.Canaris GJ, Manowitz NR, Mayor G, Ridgeway EC, "The Colorado Thyroid Disease Prevalence Study", Arch of Internal Medicine; 2000;160: 526-534 4. McDermott MT. "In the clinic: hypothyroidism". Annals of Internal Medicine; 2009;151 (11): ITC-6-1 5. Mathur, R, "Hypothyroidism", 2015. Published online at http://www.medicinenet.com/hypothyroidism/page5.htm

To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 or FDA at 1-800- FDA-1088

For more information about IBSA, visit www.ibsagroup.com/media
For Full Prescribing Information, visit www.Tirosint.com

IMPORTANT SAFETY INFORMATION

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS.

• See full prescribing information for complete boxed warning
• Thyroid hormones, including TIROSINT-SOL, should not be used for the treatment of obesity or for
• weight loss.
• Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening
• manifestations of toxicity

CONTRAINDICATIONS

• Hypersensitivity to glycerol
• Uncorrected adrenal insufficiency

WARNINGS AND PRECAUTIONS

• Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate TIROSINT-SOL at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation
• Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma
• Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT-SOL treatment
• Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism
• Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy
• Decreased bone mineral density associated with thyroid hormone over-replacement. Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose

Limitations of Use

• Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients
• Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis

Adverse Reactions
Common adverse reactions with TIROSINT-SOL are primarily those of hyperthyroidism due to therapeutic overdosage including arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash

SOURCE IBSA Pharma, Inc.

Related Links

http://www.ibsagroup.com