Thyroid Tablets USP contain the labeled amounts of levothyroxine and liothyronine, within +/- 10%, the labeled amounts being 38 mcg levothyroxine and 9 mcg of liothyronine for each 65 mg (1 grain) of the labeled content of thyroid. They must meet the microbial requirements {USP "61"} for absence of Salmonella & Escherichia coli. They must meet disintegration testing (15 minutes), uniformity of dosage unit testing, and limit of organic iodide testing (not more than 0.08%). Store in a tight container as defined by the USP.

Note: All information obtained from 1995 USP 23 NF 18, pp. 2684-2685 & 1997 USPDI-Volume III- 17th Edition., p. IV/518. Please see these references for more detail.

FULL STRENGTH THYROID PROCESSING PROCEDURE

1. The raw Pork Thyroid is collected at slaughterhouses, which operate under U.S.D.A. inspection to assure that the animals slaughtered are suitable for edible purposes. Also, the proper ante and post mortem inspections have been performed on the animals producing these raw materials.

2. The porcine Thyroid glands are held in a frozen state until delivered to the processing laboratory, and processing is begun.

3. The slightly tempered, cold thyroid glands are minced using a 3/8" (inch) diameter grinder plate.

4. The minced thyroid product is spread uniformly on stainless steel pans, which are placed then on heated shelves in a vacuum dryer.

5. The product is dried under vacuum at a shelf temperature of 71 degrees Centigrade.

6. The dried Thyroid product is defatted with hexane (C6H14) so the residual fat content is less than 5%.

7. The defatted Thyroid product is poured through a magnetic separator positioned in the hopper of a Fitz-mill, and milled to a coarse powder.

8. The Fitz-milled product is milled to a fine powder, using a ball mill containing porcelain balls.

9. Routinely, several batches of approximately 200 pounds each are combined by blending in a V-blender to create a lot of Full Strength Thyroid powder.

10. The blended Full Strength Thyroid powder is packaged in 50 kilo quantities, and usually a balance quantity in poly-lined drums, then statistically sampled using the relationship S=(N + 1, where S = number of samples and N = number of drums of product.

11. Full Strength Thyroid samples are tested for chemical and microbiological characteristics.

12. The Full Strength Thyroid is then released for sale, provided the test results indicate the product satisfactorily meets established specifications.

ACTIVE INGREDIENTS IN ARMOUR(r) THYROID AND THYROLAR(r)

ARMOUR(r) THYROID1:

T3 T4

1/4 Grain (15mg) 2.25 mcg 9.5 mcg
1/2 Grain (30mg) 4.50 mcg 19.0 mcg
1 Grain (60mg) 9.00 mcg 38.0 mcg
1 & 1/2 Grains (90mg) 13.50 mcg 57.0 mcg
2 Grains (120mg) 18.0 mcg 76.0 mcg
3 Grains (180mg) 27.0 mcg 114.0 mcg
4 Grains (240mg) 36.0 mcg 152.0 mcg
5 Grains (300mg) 45.0 mcg 190.0 mcg

THYROLAR(r):

1/4 3.10 mcg 12.5 mcg
1/2 6.25 mcg 25.0 mcg
1 12.50 mcg 50.0 mcg
2 25.00 mcg 100.0 mcg
3 37.50 mcg 150.0 mcg

1 T3 = Liothyronine, T4 = Levothyroxine
Note: T3 has approximately 4 times the biological potency of T4.

APPROXIMATE EQUIVALENT STRENGTHS OF VARIOUS THYROID PREPARATIONS, BASED ON CLINICAL RESPONSES AS TAKEN FROM THE USP-DI.

Drug ® Thyroid tablets, USP (Armour(r) Thyroid) Liotrix tablets, USP (Thyrolar(r)) Liothyronine tablets, USP (Cytomel(r)) Levothyroxine tablets, USP (Levothroid(r), Synthroid(r), ...)

Approx. Dose Equivalent 1/4 grain (15 mg) 1/4 6.25 mcg 25 mcg (.025 mg)
Approx. Dose Equivalent 1/2 grain (30 mg) 1/2 12.5 mcg 50 mcg (.05 mg)
Approx. Dose Equivalent 1 grain (60 mg) 1 25 mcg 100 mcg (.1 mg)
Approx. Dose Equivalent 1 & 1/2 grains (90mg) 1 & 1/2 37.5 mcg 150 mcg (.15 mg)
Approx. Dose Equivalent 2 grain (120 mg) 2 50 mcg 200 mcg (.2 mg)
Approx. Dose Equivalent 3 grain (180 mg) 3 75 mcg 300 mcg (.3 mg)

Note: These estimated daily doses are based on clinical evaluations. Please keep in mind that a dose adjustment may be required. Thyroid dosing is

highly patient specific and must always be individualized to achieve maximum benefit and optimal patient health.
1 United States Pharmacopoeia - Drug Information 1997, 17th Edition, Drug Information for the Health Care Professional; Vol. 1, pp. 2860-2867. Rand McNally, Taunton, MA 02780

Please don't hesitate to call or reply with any further questions or comments.

Sincerely,

Daryl Wesche, RPh
Senior Drug Information Associate
Professional Affairs Department
Forest Pharmaceuticals, Inc.
(800) 678-1605, Ext. 7037