tilbake om Armour om historien til Thyroid og thyroxin hvordan bruke Armour laget av ku og sau? den store thyroidmangelen
Det er gammeldags tørket skjoldbruskkjertel av svin, ikke ku eller sau som noen sier.
Dog fins det litt ku-Thyroid som er apoteklaget i tyskland og litt i russland men det er ikke populært. Virker ikke så bra ifølge pasientene.
I Sverige gikk det under handelsnavnet Thyranon, markedsført av Organon.
http://www.sonjas-stoffskifteforum.info/showthread.php?p=76809#post76809
Svensk side om Thyroid http://www.skoldkortelforeningen.se/svinskoldkortel_kontra_levotyroxin.html
i Italia fins det Cinetic i Tyskland Thyranon og Thyreoid, i Holland Thyreoïdum
I søk på Relis www.relis.no finner man et
par referanser på Thyroid og Armour Thyroid i databasen: tast inn thyroxin i
søkefeltet og man kommer til en veldig gammel artikkel fra 1997 som sier
at
"Thyroid er fremstilt fra biologisk materiale
(svinethyroidea) og inneholder en blanding av levothyroxin og liothyronin (1,2).
Det foreligger standarder vedrørende kvantifisering og deklarasjon av innhold
og biologisk aktivitet (2). I følge USP-standarden skal 65 mg thyroid inneholde
38 mikrogram levothyroxin og 9 mikrogram liothyronin. Mengden "1 grain"
tilsvarer 60-65 mg thyroid....
1.
Physicians' Desk Reference (PDR)
(USA) 1995: 1025.
2.
McEvoy GK, editor. American
Hospital Formulary Service (AHFS) Drug Information 1997: 2483-5.
" http://www.arnett.no/relisweb/Utredning_Ekstern.ASP?Relis=2&S=625
og fra juli 2005 "Armour Thyroid® består
av tørkede grisetyreoideakjertler. Produktet inneholder både levotyroksin (T4)
og Liotyronin (T3). Ratioen mellom T4 og T3 er 4,22:1. 30 mg produkt tilsvarer
12,5 mikrogram T3 og 50 mikrogram T4 (1). Preparatet finnes i styrkene 15, 30,
60, 90, 120, 180, 240, 300 mg (2)."
http://www.arnett.no/relisweb/Utredning_Ekstern.ASP?Relis=5&S=908
man må gå om en side hvor man bekrefter man er helsepersonnell.
(Desiccated) Thyroid var i mange årtier det eneste preparatet til behandling av lavt stoffskifte, så man har over 100 års erfaring. Det gjaldt som bra og stabilt. Men det var en historie en gang hvor det ikke var noe aktivt stoff i varen. Til sammenligning var det mange mange ganger at Synthroid har vært tilbakekalt pga. under-eller over-dose. Det har vært så mange problemer med levothyroxin i Amerika at de måtte søke om ny legemiddelsøknad. Mer om denne fantastiske historien (de nektet) finner du på neste side her.
http://www.armourthyroid.com/ er produktets hjemmeside.
Pga mangelen i USA bruker alle nå Erfa Thyroid fra Kanada. (oppdatert: Armour Thyroid er tilbake, samt NP Thyroid Acella)
Norske apotek fører Erfa THyroid og Armour Thyroid også.
Det (Erfa)er veldig bra, har den opprinnelige Armour-sammensetningen fordi de eier rettighetene fra den gangen Pfizer delte seg opp i USA og utenlands. Rettighetene ble delt men det het Armour i USA og Thyroid i Kanada. Nå er det et belgisk lememiddelkosern(Erfa) som eier rettighetene.
Oppdatert 2010: Det er mangle i USA og alle produsenter venter på en ny lov om biologics og FDA sier at de tror at ingen medisiner er grandfathered in lenger og at de må levere en NDA...det er omtrent 30 000 medisiner som faller i samem aktegori, at de er gamle, før FDA kom og de er grandfathered in.
Time Caps måtte slutte å produsere, og Major, siden de startet opp etter datoen for at grandfatered in gjaldt.
De andre som er åoppdrive, er thailandske Thiroyd og Thyroid-S, som mange kjøper når de allikevel er i Thailand.
En pdf av pakningvedlegget fins på websiden.
Det fins relativt mye informasjon om Thyroid og Armour Thyroid.
http://www.hypomaarniethappy.nl/armour.htm
http://thyroid.about.com/cs/thyroiddrugs/a/armour.htm
http://www.rxlist.com/cgi/generic3/armourthyroid.htm
http://www.thyroid-info.com/articles/mercola.htm
Bilder av tablettene: http://www.pdrhealth.com/drug_info/rxdrugprofiles/drugs/arm1029.shtml
http://www.mercola.com/article/hypothyroid/treatment.htm
http://www.antiaging-systems.com/a2z/thyroid.htm
http://www.armourinfo.freeuk.com/ Har lagt ut noen fakta, bl.a. hva USP betyr
http://www.healthrecipes.com/armour_thyroid.htm
http://thyroid.about.com/b/a/236943.htm
http://www.wellnesschiro.com/synthroid_-_what_you_need_to_know.htm
Det fins andre merker av dessicated thyroid der ute.
Time Caps Thyroid o. l. Mange heter bare Thyroid.
(Time Caps , Qualitest og major fins ikke lenger)
De som føres av firmaer som hovedseklig driver med rimeligere medisin (generics,
slik som Alpharma her) slik som Time Cap kan være ganske billige. 1000
tabletter på 1 grain koster typisk 11 dollar.
På et tysk forum sa en at 100 2-grain tabletter Thyroid USP fra Qualitest
koster 10 euro. Jer ser at Time-cap skal være billigere, noe ever 5
dollar engros mens Qualitest koster 24 dollar. http://www.kingpharm.com/uploads/pdf_vt/Levoxyl_VTprescribers.pdf
Her koster Thyroid fra Time Cap 17 dollar for 1000.
Fra Australia fant jeg en posting:
" We do have compounded THYROID USP though..just dessicated thyroid. I
get mine made up with MethocellE4M around 30% and a ground white rice filler
to achieve a slow release effect.
I suspect brand name Armour has some slow release built in which is probably
why some don't do so well on generics."
Om stabiliteten fant jeg flere bidrag på UK forumet hos thyroid.about.com.
http://forums.about.com/ab-thyroiduk/messages?msg=2608.14
"From: sheilaturne1 Aug-21 10:48 am To: ALL
Below is a document made up from extracts from monographs about the stability
of T4 and T3 in Armour Thyroid. If your doctor or endocrinologists ever
tells you again that they will not prescribe Armour because ...
1) Armour is an unreliable preparation in terms of active thyroid constituent
2) He/she is not prepared to prescribe it in view of the difficulty in ensuring adequate quality control
3) It cannot be stabilised or there are problems with batch to batch
consistency, or
4) The synthetic thyroxine is the only medication which provides steady hormone levels...
...then zap 'em with the following information.
We need to get this information out to everybody so that no longer will
we or anybody else have the wool pulled over our eyes. It appears to have
been well out of sight ever since thyroxine came onto the market!.
It was my endocrinologist (Dr. Pope) who told me that if I could get such
scientific information about the batch to batch stability of T4 and T3 in
Armour Thyroid, then we would have more chance of winning our battle
because it is them who do not believe that this information can be proved as
they have not seen any evidence. I asked Topaz to help in finding out about
this and happily she was able to obtain this from her friend who I believe is
a chemist and therefore had access to a scientific library. A good friend indeed!
I just get so cross when I think how easy it was for us to obtain
this information, so why couldn't the Society for Endocrinology find
this too and why couldn't all the professors, endocrinologists, teaching
hospitals etc., and what about the British Thyroid Foundation too????
It may well be hidden away in some dusty, boring scientific volumes that
nobody is actually interested in reading, but........
So everybody, what do you think is the best way we can we get this information out and place it where it really matters and will best make an impact on the medical establishment and the general public at large? This is what our TPA-UK group is all about! http://groups.yahoo.com/group/TPA-UK/ We don't want this pushed under the pile of blankets ever again. Such lack of knowledge and information must to be stopped now.
Luv - Sheila
PS - Topaz - I believe you have more information about how, during the testing
by these 4 laboratories, they heated the powder up to over 300 degrees C and
dampened it and it was still 'stable' and within the USP specifications eight
and a half years later. Could you post that info. for everyone to see too please?
This is just about the best news we Armour user's could have obtained. We really
are 'well armoured' should our medical practitioners still try to tell us it
is not stable.
----------------------------------
Determination of Liothyronine and Levothyroxine in Thyroid Preparations by Liquid
Chromatography
STEVEN L. RICHHEIMER AND CHARLOTTE B. JENSEN
Received February 14, 1985, from the Quality Control Laboratory, Pharmaceutical
Basics, Inc., Denver, CO 80223.
Accepted for publication November 14, 1985.
Abstract
Liothyronine and levothyroxine were quantitatively determined in samples of
commercial thyroid tablets and bulk powders. Samples were first hydrolyzed using
a bacterial protease and then analyzed by high-performance liquid chromatography.
Various hydrolysis conditions were investigated. The liothyronine and levothyroxine
contents of commercial tablets and bulk powders were found to be 8-11 mcg and
25-43 mcg, respectively, per 65 mg of thyroid. The stability of the iodothyronines
in thyroid tablets was also investigated.
The U.S.P. method[1] for the high-performance liquid chromatographic (HPLC) determination of liothyronine (T3) and levothyroxine (T4) obtained from enzymatic digestion of desiccated thyroid and thyroid tablets is based on that of Rees-Jones and Larsen.[2] These authors reported that 65 mg (1 grain) of thyroid tablets contained 12 mcg of liothyronine (T3) and 64 mcg of levothyroxine (T4), determining the iodothyronine contents by radioimmunoassay (RIA) instead of HPLC. Other investigators have reported considerably lower recoveries of liothyronine (T3) and levothyroxine (T4) following enzymatic digestion of desiccated thyroid and thyroid tablets[3-8] Initial attempts to reproduce the results of Rees-Jones and Larsen[2] using the proposed HPLC method of analysis on a variety of thyroid tablets and bulk material gave liothyronine (T3) and levothyroxine (T4) recoveries of only -50-60 of those reported. Chromatographic difficulties were encountered using the cyano column specified, and the small incubation volume (0.55 mL) made it impossible to |obtain adequate hydrolysis on most tablets in which the proportion of excipients to desiccated thyroid was large. Hence, studies were undertaken to determine the optimum conditions for the hydrolysis and chromatography of liothyronine (T3) and levothyroxine (T4) present in commercially available thyroid tablets. As a result of the studies which are 'reported here and studies performed collaboratively at other laboratories (Armour Pharmaceutical Co., Eli Lilly Pharmaceutical Co., and the National Center for Drug Analysis, Food and Drug Administration), the Pharmacopeial Convention made revisions in USP XXI via the Second Interim Revision Announcement.9 Limits of 8.19..9mg of liothyronine (T3) and 32.3-43.7 mg levothyroxine (T4) per 65 mg (1I grain) were adopted.
Experimental Section
Reagents and MaterialsU.S.P. reference standards of levothyroxine and liothyronine were used undried. Moisture content was determined by the Karl Fischer titration method, and a correction was made. L-3,3',5'-triiodothyronine (T3, reverseT3, or iso-T3, Calbiochem-Behring Corp., San Diego, CA) was used as received. Bacterial protease derived from Streptomyces griseus was obtained from two sources (Pronase, catalog #53702, Calbiochem-Behring ;Corp.; Bacterial Protease, catalog #P5147, Sigma Chemical Co., St. ;Louis, MO). Reagents used were analytical reagent grade, and acetonitrile was HPLC grade. Iodine assays were done by potentiometric titration using silver nitrate and an iodide-sensing electrode.[10] Thyroid tablets were obtained from several manufacturers (Pharmaceutical Basics, Inc., Denver, CO; Armour Pharmaceutical Co., Scotsdale, AZ; Eli Lilly Co., Indianapolis, IN), and bulk thyroid was either full strength (-0.8 iodine, American Laboratories, Inc., Omaha, NE) or cut with lactose to 0.2 iodine content (Pharmaceutical Basics, Inc., Denver, CO).
ApparatusThe high-performance liquid chromatograph (HPLC) (model 5500, Varian Instruments, Palo Alto, CA) was equipped with a variable-wavelength detector (Varian model UV-200), column heater, auto sampler (Varian model 8000), and auto injector (model 7126, Rheodyne Corp., Cotati, CA) with a 200-L loop. Data was handled by a chromatographic data system equipped with a 144K memory, disk storage, and a printer plotter (Varian, Vista 402). A commercially available 4 mm ID x 30 cm octadecylsilane column (A-Bondapak-Cia, Waters Associates, Milford, MA) was used.
Chromatographic ConditionsThe mobile phase was a mixture of 28 acetonitrile and 72 of a 1:200 mixture of phosphoric acid in water. The percentage of acetonitrile was increased to about 35 when a spherical 5-/nm Cig column packing was used. The flow rate was either 1.5 or 2.0 mL per minute, the column temperature was 34°C, and the detector was set at 225 nm.
Proteolytic Enzyme SolutionA pH 8.4 reducing buffer solution was prepared containing 0.11 M NaCI, 0.04 M Tris buffer, and 0.05 M methimazole. The pH was adjusted to 8.4 ± 0.05 with 6 M HC1. On the day of use the proteolytic enzyme was dissolved in the reducing buffer to prepare a solution containing 150 protease units per milliliter (1 unit liberates a digestion product equivalent to 25 µg of tyrosine per minute).
Stock Standard SolutionsLevothyroxine (95 mg) was dissolved in 100 mL of a 500:500:1 mixture of water:acetonitrile:ammonia hydroxide. Similarly, liothyronine (22.5 mg) was dissolved in 25.0 mL of the same mixture. A working combination stock solution was then prepared by combining 4.0 mL of the levothyroxine stock and 1.0 mL of the liothyronine stock and diluting to 10.0 mL with a 1:1 mixture of acetonitrile and water. This combination stock was stable for -2 months when stored at 4°C in the dark.
Working StandardOn the day of use, the combination stock was diluted 1:50 with the reducing buffer solution. Then, 2.0 mL of enzyme deactivating solution (1:100 phosphoric acid:acetonitrile) was added to 5.0 mL of the diluted standard. The final concentrations of liothyronine (T3) and levothyroxine (T4) were -1.3 mcg/mL and 5.4 mcg/mL, respectively.
Recovery StandardThe combination stock standard was diluted 1:50 with proteolytic enzyme solution instead of reducing buffer and treated in the same manner as the samples. Sample PreparationAn accurately weighed portion of powder equivalent to 65 mg (1 grain) of thyroid (proportionately less was used if the iodine content was greater than 0.2) was transferred to a screw-capped culture tube, 5.0 mL of proteolytic enzyme solution was added, and the contents were mixed well. The tubes were placed in an incubator maintained at 37 ± 1°C, and the contents were agitated after 4-8 h and again after 20-24 h. At the end of the incubation period (28 h); 2.0 mL of enzyme deactivating solution was added, and the tubes were mixed well, and centrifuged at about 2000 rpm for 5-10 min. Some samples required filtration through a 0.45-/xm membrane filter in order to clarify the sample.
Results and Discussion
ChromatographyFigure 1 shows a typical chromatogram obtained for a 65-mg thyroid tablet. The small peak at 14 min had the same retention time as L-,3',5'-triiodothyronine CIV, 1). The approximate amount of 1 was found to be about 1.0-1.6 /zg/65 mg of thyroid. The presence of 1 in thyroid has also been reported by other investigators,4-7 and its presence in samples precluded the use of 1 as a convenient internal standard.
0022-3549/86/0200-0215$01.00/0
© 1986, American Pharmaceutical Association
Journal of Pharmaceutical Sciences/215 Vol. 75, No. 2, February 1986
OPEN FORUM
Liothyronine and Levothyroxine in Armour Thyroid
The current United States Pharmacopeia (U.S. Pharmacopeia) method[1] for the analysis of liothyronine (T3) and levothyroxine (T4) in desiccated thyroid requires a proteolytic enzymatic digestion followed by a high-performance liquid chromatographic assay. These procedures were validated through a collaborative study at four laboratories[2] in which one-grain thyroid tablets from three manufacturers were assayed in triplicate on five consecutive days. The final results of this study were submitted to the U.S. Pharmacopeia to assist them in establishing both the analytical procedures and the specifications for thyroid tablets, U.S.P.
In the February, 1986 issue of the Journal of Pharmaceutical Sciences, Richheimer and Jensen of Pharmaceutical Basics[3] published further data developed on thyroid products manufactured by Armour, Lilly, and Pharmaceutical Basics. The Pharmaceutical Basics data suggest that the Armour product failed to meet the current U.S. Pharmacopeia specifications for T3 (i.e., 8.1-9.9 µg/grain). Not included in the publication were the original data that were obtained from all the participating laboratories, including Pharmaceutical Basics, Inc. (PBI), and submitted to the U.S. Pharmacopeia. These results formed the basis for the current U.S. Pharmacopeia specifications for T3 and T4 in natural thyroid. The original results obtained for the Armour product (Lot 1516), as well as PBI published data, are shown in Table I.
It can be clearly seen that with the exception of the second set of results provided by Pharmaceutical Basics, the Armour 1-grain (65 mg) thyroid product contains levels of liothyronine and levothyroxine that are well within the limits specified by the U.S. Pharmacopeia. It is interesting to note that the overall composite values for liothyronine and levothyroxine are quite similar to the mean values of the two sets of results from Pharmaceutical Basics. Additionally, the precision of the assay as demonstrated by Armour, Eli Lilly, and the FDA was significantly better than that obtained by Pharmaceutical Basics for their first analysis and for levothyroxine in the second set of data.
The above results should serve to correct any misrepresentations (implied or otherwise) reported previously regarding the liothyronine and levothyroxine content in Armour thyroid medications and the nature of the collaborative study for the U.S. Pharmacopeia. As determined by Armour Pharmaceutical Company and other participating laboratories, the liothyronine and levothyroxine content in Armour thyroid is well within the specifications set by the U.S. Pharmacopeia. The precision of the assay procedure as determined by Armour, Eli Lilly, and the FDA is considerably better than that reported by Pharmaceutical Basics.
Table I Liothyronine (T3) and Levothyroxine (T4) Content in Thyroid tablets
Laboratory.......Analysis .......iothyronine (T3)Mean ..Range .....RSD ..............Levothyroxine(T4)Mean...Range..............RSD
Armour.. ...................................................8.88............................................................................37.68
Eli Lilly...............14...................................8.58..8.58 - 9.04.1.81..............................................37.30....36.62 - 38.32...1.39
FDA....................15..................................8.60...8.33 - 8.76..2.99............................................39.47...35.6 - 38.2........3.26
PBI (1)................13.................................9.51....7.73 - 9.65...6.43............................................40.9038.19 - 40.50......3.30
PBI (III)................13.................................7.96....8.57 - 11.21..7.9.............................................36.6634.16 - 45.48......9.9
Composite..............................................8.71.....7.27 - 8.56....5.3 ...........................................38.3033.53 - 44.27.......8.1
PBIMean ............................................8.74...............................................................................38.78,............................
References and Notes
1 US Pharmacopeia, 21st rev.; U.S. Pharmacopeial Convention: Rockville, MD,
1985; pp 1893-1895.
2. Armour Pharmaceutical Company, Eli Lilly Pharmaceutical Company, The National
Center for Drug Analysis (FDA), and Pharmaceutical Basics, Inc.
3. Richheimer, S. L.; Jensen, C. B. J. Pharm. Sci. 1986, 75, 215-217.
KARL R. BLUMBERG WILLIAM J. MAYER DILIP K. PARIKHLORNE A. SCHNELL
Armour Pharmaceutical Company P.O. Box 511 Kankakee, IL 60901
Received October 22, 1986. Accepted for publication February 3, 1987.
Response to "Liothyronine and Levothyroxine in Armour Thyroid"
We originally conducted the collaborative study to determine the levothyroxine (T4) and liothyronine (T3) content of thyroid tablets from three different manufacturers in late September, 1984. Because of a deadline we had to send these results to R. Gamick at Armour Pharmaceutical Co. even though we were not happy with the results; that is, the T4 and T3 levels we found were 10-15% higher than we had gotten before and others had reported. As a result of this, we initiated a study to determine the cause of this anomaly and found that our standard stock solution had undergone extensive degradation (probably from being inappropriately stored at room temperature for several days). We then repeated the study using fresh standards and reported these new results directly to the U.S. Pharmacopeia on October 19, 1984, with instructions to disregard the previous data we had obtained. This second set of data is what is reported in our paper in the February 1986 issue of the Journal of Pharmaceutical Sciences. To the best of our knowledge this set of data was in the hands of the U.S. Pharmacopeia Committee on Revision when they decided upon the final specifications for thyroid tablets.
STEVEN L RICHHEIMER CHARLOTTE D. JENSEN
Quality Control Laboratory Pharmaceutical Basics, Inc. Denver, CO 80223
a. USP XXl specification: 8.1 to 9.9 mcg/65mg (1 grain) b. USP specification: 32.3 to 43.7mcg/65mg (1 grain) c.Lot 1516; 1-grain, tablets. d. pharmaceutical basics, Inc e. reference 3"
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Diverse jeg har samlet på om Armour Thyroid over flere år:About Armour Natural thyroid:
__from Forest Pharmaceuticals
Armour Thyroid is indicated as a replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults and the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of the thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism. It is also indicated as a pituitary TSH suppressant, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, sub-acute or chronic lymphocytic thyroiditis (Hashimoto's), multinodular goiter, and in the management of thyroid cancer. It is also indicated as a diagnostic agent in suppression tests used to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Armour Thyroid is obtainable only via a prescription from your prescribing practitioner. Any local pharmacy should be able to provide you with this product so long as you obtain a prescription for the medication. Armour Thyroid is a natural preparation of USP grade desiccated thyroid powder derived from porcine (pork) thyroid glands. Each tablet provides 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid, which approximates the human biological potency of T3 and T4. Other ingredients (inactive), in Armour Thyroid tablets include calcium stearate, dextrose, microcrystalline cellulose, sodium starch glycolate, and opadry white. Armour Thyroid is available in 1/4 grain, 1/2 grain, 1 grain, 11/2 grain, 2 grain, 3 grain, 4 grain, and 5 grain tablet strengths.1 Armour Thyroid meets all the requirements set by the United States Pharmacopoeia (USP) for thyroid medications and manufacturing specifications are tightly controlled, contrary to current misconceptions of desiccated thyroid. Because Armour Thyroid preparations require a 4.22 to 1 ratio of T4 to T3 , batches of desiccated thyroid are mixed until the desired ratio is obtained and verified via analytical methods. This method ensures that each strength of Armour Thyroid will be consistent every time. So long as the patient is appropriately dosed, in accordance with both clinical symptoms and thyroid lab values, anticipated circulating thyroid hormone levels should also remain consistent. ******* Before thyroid panel tests are performed, it may be advisable to have the patient skip their normal morning dosage to avoid erratic lab values in respect to T3 levels. The patient should then be advised to take their daily dose of thyroid immediately following the blood draw for thyroid panel testing. The same holds true for patients taking any form of liothyronine due to the rapid peak onset of action. ****** __________end from from Forest Pharmaceuticals