How Armour is made... dosage equivalents for various thyroid meds

[Guest guest]

For those that have wondered how Armour is made or what the equivalencies are for the various thyroid meds... I finally got around to charting the numbers so that they are easier to compare.... Hoping, of course, that the formatting comes through... if not I'll try to get the doc file to the files section off the group home page so you can down load it for your records.

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Armour Thyroid USP Guidelines

http://www.armourthyroid.com/index.html

Thyroid USP is the cleaned, dried and powdered thyroid gland previously deprived of connective tissue & fat.

Description: Yellowish to buff-colored, amorphous powder, having a slight, characteristic, meat like odor. It is obtained by domesticated animals that are used for food by humans. It meets the USP microbial requirements for the tests (USP “61”) of absence of Salmonella & Escherichia coli. Thyroid USP must meet loss on drying tests (USP “731”) with loss of not more than 6% of it’s weight. Thyroid USP must meet inorganic iodide testing with a limit of 0.01%. Thyroid USP desiccated powder must yield not less that 90% and not more than 110% of the labeled amounts of levothyroxine and liothyronine.

Thyroid Tablets USP contain the labeled amounts of levothyroxine and liothyronine, with +/- 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 that 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

The raw Pork Thyroid is collected at slaughterhouses, which operate under the 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. The porcine Thyroid glands are held in a frozen state until delivered to the processing laboratory, and processing is begun. The slightly tempered, cold thyroid glands are minced using a 3/8” (inch) diameter grinder plate. The minced thyroid product is spread uniformly on stainless steel pans, which are placed then on heated shelves in a vacuum dryer. The product is dried under vacuum at a shelf temperature of 71 degrees Centigrade. The dried Thyroid product is defatted with hexane (C6H14) so the residual fat content is less than 5%. The defatted Thyroid product is poured through a magnetic separator positioned in the hopper of a Fitz-mill, and milled to a coarse powder. The Fitz-milled product is milled to a fine powder, using a ball mill containing porcelain balls. 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. 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. Full Strength Thyroid samples are tested for chemical and microbiological characteristics. The full Strength Thyroid is then released for sale, provided the test results indicate the product satisfactorily meets established specifications.

Active Ingredients in Armour Thyroid ® and Thyrolar ®

Armour ® Thyroid 1

T3 (mcg)

T4 (mcg)

¼ grain (15 mg)

2.25

9.50

1/2 grain (30 mg)

4.50

19.00

1 grain (60 mg)

9.00

38.00

1 ½ grains (90 mg)

13.50

57.00

2 grains (120 mg)

18.00

76.00

3 grains (180 mg)

27.00

114.00

4 grains (240 mg)

36.00

152.00

5 grains (300 mg)

45.00

190.00

Thyrolar ®

T3 (mcg)

T4 (mcg)

¼

3.10

12.50

½

6.25

25.00

1

12.50

50.00

2

25.00

100.00

3

37.50

150.00

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.

Thyroid Tablets, USP

(Armour ® Thyroid)

¼ grain

(15 mg)

½ grain

(30 mg)

1 grain

(60 mg)

1 1 /2 grain

(90 mg)

2 grain

(120 mg)

3 grain

(180 mg)

Liotrix Tablets, USP

(Thyrolar ®)

¼

½

1

1 ½

2

3

Liothyronine Tablets, USP

(Cytomel ®)

6.25 mcg

12.5 mcg

25 mcg

37.5 mcg

50 mcg

75 mcg

Levothyroxine Tablets, USP

(Levothroid ®, Synthroid ®)

25 mcg

(.25 mg)

50 mcg

(.50 mg)

100 mcg

(.1 mg)

150 mcg

(.15 mg)

200 mcg

(.2 mg)

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.

, Ext. 7037