SYNTHROIDGroup 2: Caroline Habjan and Ryan Ullrich

Monday, November 17th, 2014

An endocrine gland that secretes hormones, collectively

called the thyroid hormones, that influence:

Metabolism

Growth and Development

Body Temperature

Normal Cognition

Bone Health

Cardiovascular Function

The Thyroid

Thyroid Hormones: Tyrosine-based hormones

Triiodothyronine (T3)

Thyroxine (T4)

Prohormone of T3

Iodine is necessary for the production of T3 and T4

Sodium supplementation necessary

Sodium is supplemented with Iodine

Thyroid Hormones: Metabolism

Regulators

The thyroid gland:

Is “under-active”

Does not produce enough thyroxine

According to the American Thyroid Association:

2-3% of Americans have hypothyroidism

50% of of affected individuals don’t know they have

hypothyroidism

Hypothyroidism

Several:

Surgery to remove the thyroid gland

Radiation for cancer therapy

Viral infection

Some drugs such as:

Amiodarone

Lithium

Causative Factors of Hypothyroidism

Symptoms: Fatigue

Increased sensitivity to cold

Constipation

Dry skin

Unexplained weight gain

Puffy face

Hoarseness

Muscle weakness

Elevated blood cholesterol level

Muscle aches, tenderness and stiffness

Pain, stiffness or swelling in your joints

Heavier than normal or irregular menstrual periods

Thinning hair

Slowed heart rate

Depression

Impaired memory

Symptoms and DiagnosisDiagnosis:

Simple Blood

Test

Hypothyroidism medication replaces the thyroxine the

thyroid gland can't make enough of naturally anymore.

Benefits of LT4 include:

Very accurate tablet standards

Stable absorption

Steady blood levels

Good tolerability

Thyroxine Replacement Therapy

Our Product

Minimal to zero dosage error

Patient specific dosage quantities pre-measured.

Convenience for patients

Reduced medical costs for patients and practices

Fewer patient visits

Less health professional administration

Reduced degradation of active ingredients

→ Regulated, stable doses

→ Patients can more easily achieve homeostasis

Why have we chosen SYNTHROID?

Each pill contains a synthetic crystalline L-3,3',5,5'-

tetraiodothyronine sodium salt.

Levothyroxine (LT4)- Synthetic hormone that has the

identical chemical structure and formula to natural

thyroxine.

Sodium (for an iodide source)

microcrystalline cellulose.

Inactive ingredientsAcacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium

stearate, povidone, and talc

SYNTHROID: Scientific and

Technological Development

1. Synthetic levothyroxine (LT4) →

2. Supplies FT4 to the body →

3. The body converts FT4 to FT3 (deiodination)→

4. Homeostatic levels of thyroid hormone are restored

LT4 is effective for the vast majority of patients

Mechanism of LT4

GI Tract

Absorbed

Cell

T4 and T3 diffuses through the membrane

Thyroid Receptors

Gene transcription, synthesis of messenger

RNA,cytoplasmic proteins.

SYNTHROID: Scientific and

Technological Development

Potency

Big Problem in thyroid hormone industry.

stability.

Advantage

Microcrystalline Cellulose

increases stability

binds less to T4

SYNTHROID: Product Differentiation

Synthroid does not hold any patents.

AVICELU.S. Pat. Nos. 5,955,105 and 6,056,975

SYNTHROID: Patent Ownership

Abbott Laboratories

100 Abbott Park Road,

North Chicago, IL 60064General Information: (847) 937-

6100

Pharmaceutical Product Issues:

(800) 255-5162

Synthroid is the only

hypothyroid medication that

Abbott manufactures.

SYNTHROID Manufacturer

SYNTHROID: Sales

SYNTHROID: Sales

Total 2013 Sales:

$837,607

9,759 units

Only thyroxine replacement drug company in the Top

(Earning) 100 Pharmaceutical Companies

SYNTHROID: Sales

In 2004, 62% of patients treated for hypothyroidism chose

SYNTHROID.

By 2018, it is expected for the value of the global

hormone replacement therapy market rise to

approximately 3.6 billion dollars.

SYNTHROID: Sales

“I have been using Synthroid for over ten years and find it the best to use.”

“Since switching to the brand name Synthroid, I am

experiencing all the benefits of the generic WITHOUT

any headaches or side effects; no insomnia, no weight

gain (actually am losing weight at about 2lbs a week),

no brain fog, no depression.”

“Since my doctor convinced me to switch to Synthroid, I have noticed that I

have more energy in the mornings and more color to my face.”

Patients are MOST satisfied with

SYNTHROID!!

Drug Manufacturer Active Differentiator

Armour Thyroid

Forest Pharmaceuticals Natural, Differentiated Thyroid

Bio-Throid BIO-TECH Pharmaceuticals, Inc. Natural, Differentiated Thyroid

Cytomel King Pharmaceuticals Liothyronine, synthetic T3 Hormone

Levothroid Forest Pharmaceuticals Levothyroxine

Levoxyl King Pharmaceuticals Levothyroxine

Levo-T Mova Pharmaceuticals Levothyroxine

Naturethroid Western Research Laboratories Natural, Differentiated Thyroid

Thyrolar Forest Pharmaceuticals Liotrix, combination of T3 and T4

Unithroid Jerome Stevens Pharmaceuticals Levothyroxine

Westroid Western Research Laboratories Natural, Differentiated Thyroid

SYNTHROID Competition

Some patients have slight abdominal discomfort

Recommended Remedy:

Tablet composed of:Remove 50% Microcrystalline Cellulose

Contributes to the long half life of Synthroid; slow

digestion/absorption rates by humans.

Add 50% Glucose

Sugar metabolized/absorbed more readily by the

human body.

→ Maximizes patient comfort and satisfaction and

still maintains high effectiveness.

Recommended SYNTHROID Improvements

Questions???

Synthroid https://www.synthroid.com/livingwith/default.aspx

Panicker, Vijay. Genetics of Thyroid Function and Disease. Clin Biochem Rev; Nov 11 32(4): 165-175.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3219766/

Shomon, Mary. Thyroid-Info. 2003.http://www.thyroid-info.com/drugs/westhroid.htm

MayoClinic: Hypothyroidismhttp://www.mayoclinic.org/diseases-conditions/hypothyroidism/basics/symptoms/con-20021179

Synthroid®

(levothyroxine sodium tablets, USP)http://www.drugs.com/pro/synthroid.html

Levothyroxine compositions and methodshttp://www.google.com/patents/US6555581

Stable dosage of levothyroxine sodium and process of production

http://www.google.com/patents/US5225204

Hormone Replacement Therapy Market - Global Industry Size, Share, Trends, Analysis And Forecasts 2012 - 2018http://www.transparencymarketresearch.com/hormone-replacement-therapy-market.html

Works Cited