Thyroid USP (GMP)

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Thyroid Powder is easily absorbed by human body and shown to have less side effects compared to synthetic drugs in the treatment of Hypothyroidism

Mechanism of action

The thyroid gland plays a major role in the metabolism and development of the human body. It constantly produces and releases thyroid hormones into the bloodstream, Liothyronine (T3) and Levothyroxine (T4) being the major players. These hormones are essential for normal development, growth, neural differentiation and metabolic regulation (Brent, 2012).
They function by increasing the basal metabolic rate (BMR) and needed to stay warm, have strong heartbeat and in general increasing the energy usage of the body.

BIOFAC manufactures Thyroid Powder from porcine thyroid gland according to USP with standardized content of both T3 and T4 hormones.
The oral products with Thyroid Powder is a well-known option for patients with hypothyroidism.

Advantages of Thyroid Powder compared to synthetic T4

A recent study showed that about half of all patients preferred natural thyroid powder containing T3 and T4, compared to only synthetic T4, primarily due to fewer side effects (Hoang et al., 2013). The hormones are easily absorbed and the powder can therefore be administered orally. As it is important to have balanced levels of thyroid hormones, intake of thyroid powder should not be overdosed. To enable careful dosing of hormones Biofac Thyroid Powder is produced according to USP standards.

Storage and Stability

BIOFAC Thyroid Powder is a hygroscopic product that easily absorbs humidity from the air. It should be stored in original and tightly closed containers at room temperature not exceeding 25 C. The re- test date is 2 years from the date of production if stored as advised above.

Thyroid Hormons

The thyroid gland is located in the front lower part of the neck. Hormones released by the gland travel through a bloodstream and affect nearly every part of the body, from heart and brain, to muscles and skin.
T4 is the primary isoform of thyroid hormone produced in the thyroid gland whereas the active form, T3, is produced to a lesser extent. In target tissues deiodinases are responsible for the conversion of T4 to T3, a process necessary due to T3’s higher affinity for thyroid hormone receptors (Aranda, A., Alonso-Merino, E. and Zambrano, A. (2013) ‘Receptors of thyroid hormones.’, Pediatric endocrinology reviews : PER).

Hypothyroidism: Causes and symptoms

Hypothyroidism, or underactivethyroiddisease, is a state when thyroid gland does not produce enough thyroid hormones. It is a rather common disorder followed by weight gain, poor ability to tolerate cold, a feeling of tiredness, constipation, depression, fatigue and slow reflexes amongst other symptoms. The illustration above demonstrates major causes of Hypothyroidism.

Raw material safety standards

The raw material for BIOFAC Thyroid Powder are porcine thyroids from animals controlled by an official veterinarian and found fit for human consumption

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Regulatory Compliance

  • GMP certificate by Danish Medicines Agency
  • All biological raw materials utilized at the factory have been veterinary controlled and fulfil EU requirements.
  • Danish Environmental Protection Agency (Danish EPA) has made a categorization of BIOFAC as to an instruction
    No. 6 of 2004 on Differential Environmental Review and assessed that BIOFAC is classified as Category 1 (the best
    category) because of the high level of systematism and high level of regulatory compliance.
  • Danish Working Environment Authority has assigned BIOFAC with a green Smiley, indicating that BIOFAC has no
    issues with the Working Environment Authority, providing a high level of health and safety.
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