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SYNTHROID
Group 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 Diagnosis
Diagnosis:
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 ingredients
Acacia, 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.
AVICEL
U.S. Pat. Nos. 5,955,105 and 6,056,975
SYNTHROID: Patent Ownership
Abbott Laboratories
100 Abbott Park Road,
North Chicago, IL 60064
General 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: Hypothyroidism
http://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 methods
http://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 - 2018
http://www.transparencymarketresearch.com/hormone-replacement-therapy-market.html
Works Cited

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BIO 463 Synthroid Group Presenation

  • 1. SYNTHROID Group 2: Caroline Habjan and Ryan Ullrich Monday, November 17th, 2014
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. Several: Surgery to remove the thyroid gland Radiation for cancer therapy Viral infection Some drugs such as: Amiodarone Lithium Causative Factors of Hypothyroidism
  • 6. 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 Diagnosis Diagnosis: Simple Blood Test
  • 7. 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
  • 9. 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?
  • 10.
  • 11. 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 ingredients Acacia, confectioner's sugar (contains corn starch), lactose monohydrate, magnesium stearate, povidone, and talc SYNTHROID: Scientific and Technological Development
  • 12. 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
  • 13. 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
  • 14.
  • 15. Potency Big Problem in thyroid hormone industry. stability. Advantage Microcrystalline Cellulose increases stability binds less to T4 SYNTHROID: Product Differentiation
  • 16. Synthroid does not hold any patents. AVICEL U.S. Pat. Nos. 5,955,105 and 6,056,975 SYNTHROID: Patent Ownership
  • 17. Abbott Laboratories 100 Abbott Park Road, North Chicago, IL 60064 General Information: (847) 937- 6100 Pharmaceutical Product Issues: (800) 255-5162 Synthroid is the only hypothyroid medication that Abbott manufactures. SYNTHROID Manufacturer
  • 20. Total 2013 Sales: $837,607 9,759 units Only thyroxine replacement drug company in the Top (Earning) 100 Pharmaceutical Companies SYNTHROID: Sales
  • 21. 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
  • 22. “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!!
  • 23. 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
  • 24. 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
  • 26. 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: Hypothyroidism http://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 methods http://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 - 2018 http://www.transparencymarketresearch.com/hormone-replacement-therapy-market.html Works Cited