1.What is Fluticasone Propionate?
Definition:
Fluticasone propionate belongs to a class of drugs known as corticosteroids. It is used to manage asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis "e.g., itchy or runny nose, sneezing, watery eyes," emphysema, and inflammatory pruritic dermatoses.
It is available as nasal sprays, inhalers, and topical treatments for the management of inflammatory conditions.
It was first approved for medical use by FDA in 1990. Besides, it is safe and effective for pediatric patients aged 4 years and older.
It is available in both over-the-counter (OTC) or with a doctor's prescription, and it is used alone or combined with other medications.
It is available in BP/IP/USP pharmaceutical grades.
Chemical & Physical Properties:
Chemical structure:
Molecular weight: 500.6
Molecular formula: C25H31F3O5S
CAS no 80474 14 2
IUPAC name: [(6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9-difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
DrugBank accession number: DB00588
Synonyms: Flovent, Flixotide
Melting point: 261-273 °C
Storage temperature: Between 4° and 30°C (39° and 86°F).
Solubility: Insoluble in water, freely soluble in DMSO, and slightly soluble in 95% ethanol.
Elimination half-life: Approximately 7.8 hours
Brand names:
Flonase®, Flovent®, Fluticare®, Cutivate®
2.Fluticasone propionate mechanism of action.
Although the specific mechanism of action is still unclear, binding and activating the glucocorticoid receptor by corticosteroids result in a direct inhibitory effect on inflammatory mediators such as prostaglandins and leukotrienes.
Fluticasone propionate has a direct effect on β2-adrenergic receptors, which reduces mucus gland secretion.
Also, fluticasone propionate directly reduces inflammatory cells such as monocytes, mast cells, eosinophils, and macrophages, which accordingly affect cytokine production.
3.Fluticasone propionate forms and specifications.
Fluticasone Propionate API powder
Sold by: Century Pharmaceuticals Limited, Vadodara, Gujarat
Application: Commercial
CAS No: 80474 14 2
API form: Powder
Color: White
Country of origin: India
The product complies as per BP 2018 specifications.
Fluticasone propionate nasal spray
The spray is an aqueous suspension containing 50 mcg of fluticasone propionate in each 100 mg of the spray, and it is used to treat allergy symptoms such as hay fever.
It must be used at regular intervals because the drug's efficacy is related to regular usage. The spray bottle must be shaken gently before use.
During spraying, a deep inhalation should be taken via the nose, and the spray is contradicted in patients with hypersensitivity to the drug or any of its components.
Futicasone propionate cream
Fluticasone propionate cream is a topical steroid with anti-inflammatory properties, and it is used to treat symptoms of corticosteroid-responsive dermatoses, atopic dermatitis, and skin irritation associated with various skin conditions such as eczema.
The cream is available on prescription, and it is sold under the brand name CUTIVATE®.
The cream must be used on the skin only, not the face or eyes, unless directed otherwise.
A thin layer is applied to a washed and dry skin and followed by a gentle rubbing.
The cream is used according to the doctor's instructions and may be used with caution in children aged 3 months or more.
The cream should not be used in patients with hypersensitivity to the drug or any of its components such as formaldehyde as it may prevent the healing process.
Futicasone propionate inhaler
According to the drug's FDA-approved label, a fluticasone propionate inhaler is an inhaled corticosteroid that is indicated for the maintenance treatment of asthma in adults and as prophylactic therapy in children aged 4 years and older. Besides, it is used for the treatment of respiratory conditions, including COPD.
However, it is not indicated for relieving acute bronchospasm, and it is used via oral route only.
The inhaler is available on prescription, and it is sold under the brand FLOVENT HFA®.
Shaking is required before inhalation, and to enhance the drug delivery for young patients, a valved holding chamber and mask can be used.
After inhalation, the mouth must be washed with water and then spit to avoid the risk of oropharyngeal candidiasis.
5.Fluticasone propionate and salmeterol inhalation powder
Fluticasone propionate and salmeterol formulation is a combination of a steroid (fluticasone propionate) and a bronchodilator (salmeterol). It is used for the prevention of asthmatic attacks and to relieve symptoms of COPD.
Fluticasone propionate reduces the swelling in the airways, and salmeterol, a long-acting beta-agonist (LABA), causes relaxation of the lung smooth muscles, facilitating the breathing process.
The medication mixture is sold under the brand names Advair Diskus®, Advair HFA®, AirDuo RespiClick®.
The medication comes in two forms: an inhalation solution and powder.
6.Fluticasone propionate vs fluticasone furoate.
The names similarity and the active ingredients between fluticasone furoate spray (Avamys™ by GlaxoSmithKline Inc.) and fluticasone propionate made confusion as both share the steroidal backbone (fluticasone) and differ in the ester substituent (furoate/propionate).
Data showed that both drugs share similar clinical efficacy, and both treat allergic rhinitis. However, they differ in the medication strengths and dosage at different ages.
7.Fluticasone propionate uses.
Fluticasone propionate is a corticosteroid with anti-inflammatory properties, and it is available in different routes that depend on the patient's diagnosis.
Oral formulations:
Including a dry powder inhaler, a metered-dose inhaler, or a swallowed form are FDA-approved for the treatment of asthma, besides the off-label' indications for treatment of COPD and eosinophilic esophagitis.
Topical preparations:
Including cream and ointments are indicated to treat inflammatory skin conditions such as atopic dermatitis, dermatoses, eczema, and psoriasis.
Fluticasone sprays:
Indicated for the treatment of allergic rhinitis.
8. Fluticasone propionate dosage.
Adults: 2 sprays per nostril once daily (200 mcg per day).
Children aged 4 years and older: 1 spray per nostril once daily (100 mcg per day).
The recommended starting dosage of the oral inhalation according to the drug's FDA-approved label is based on previous asthma therapy as follows:
Bronchodilators alone: 88 mcg twice a day
Inhaled corticosteroids: 88-220 mcg twice a day
Oral corticosteroids: 440 mcg twice a day
Patients aged 4-11 years: 88 mcg twice a day
9.Fluticasone propionate side effects
The most common side effects include headache, nausea, vomiting, cough, nose burning/irritation/ulceration, epistaxis, and pharyngitis.
4.Fluticasone propionate manufacturing process.
The inactive ingredients in fluticasone propionate nasal spray include:
microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w phenyl ethyl alcohol. PH is adjusted between 5 and 7.
The inhalation formula contains:
A mixture of micronized fluticasone propionate (50, 100, or 250 mcg) in 12.5 mg of the formulation containing lactose monohydrate.
The creamy preparation contains:
A mixture of excipients including liquid paraffin, cetostearyl alcohol, isopropyl myristate, cetomacrogol 1000, propylene glycol, imidurea, sodium phosphate, citric acid monohydrate, and purified water.
10.Fluticasone propionate Active Pharmaceutical Ingredient (API) price
The average price is $34,261 (USD/kg)
11.Manufacturers of fluticasone propionate API in china
Below are some trustworthy manufacturers who are professional in making API active pharmaceutical ingredient.
Zhejiang Xianju Junye Pharmaceutical Co., Ltd.
The company is specialized in the manufacturing of active pharmaceutical ingredients (APIs) & intermediates, and their main sales markets include the USA, Europe, East Asia (e.g., India, Japan), and Africa.
Category: Bio Products > Sera and Vaccines
Product Name: Fluticasone propionate
CAS No: 80474-14-2
Standard: In-house Standards
Supplier address: Taizhou, Zhejiang Province, China
The supplier contact number: +86-576-88476367
Aurisco Pharmaceutical Co., Ltd.
A trading company and a manufacturer of APIs, intermediates, and high-quality pharmaceutical services for both domestic and global markets, including the USA, East Asia (e.g., India, Japan), and Eastern/Western Europe.
Category: Active Pharmaceutical Ingredients > Hormones
Product Name: Fluticasone propionate
CAS No: 80474-14-2
Status: US DMF, CEP/COS
Supplier address: 1701 Hitech Plaza 488 S Wuning Road, Shanghai, China
The supplier contact number: +86-21-52987136
SINO CARING PHARMACEUTICAL DEVELOPMENT (SUZHOU) CO., LTD
A manufacturer and supplier of high-quality Active Pharmaceutical Ingredients (APIs), formulations, and excipients with a global sales market that include the United Kingdom, Italy, India, Japan, South Korea, The United States, etc.
Category: Active: Active Pharmaceutical Ingredients
Product Name: Fluticasone Propionate
CAS No: 80474-14-2
Standard: In-house Standards
Supplier address: 1601, Building B, International Trading Center, No.12, Huanghe Road, ChangShu, Jiangsu Province, China
The supplier contact number: +86-512-52091522/ 52861060
Biosyn Healthy Pharma Co., Ltd.
Biosyn Healthy Pharma (Jiangxi) is a high-technical based manufacturer which produces API and intermediates used in the pharmaceutical field.
Their facility includes a synthesis workshop, fermentation workshop, and GMP workshop to produce high-quality products and professional services.
Their high-quality products are exported to Italy, India, Japan, and the USA.
Category: Active Pharmaceutical Ingredients
Product name: Fluticasone propionate
CAS No: 80474-14-2
Supplier address: Huangjin South Avenue, Huangjindui Industrial Park, Shanggao County, Jiangxi, China
The supplier contact number: +86-22-83865698
Asia Talent Chemical Limited.
ASIA TALENT CHEMICAL is now one of the leading suppliers, manufacturers, and service providers in China for Active Pharma Ingredients, chemicals, pharmaceuticals raw materials, herbals, phytochemicals, & intermediates, packaging, excipient, and OEM preparation.
Their global sales market includes different countries such as the United States, Europe, India, Japan, and Australia.
Category: Active Pharmaceutical Ingredients > Antibiotics > Other Antibiotics
Product name: Fluticasone propionate
CAS No: 80474-14-2
Standard: USP, In-house Standards
Supplier Address: RM721, EAST BLOCK, COASTAL TIME BUSINESS OFFICE.SHENZHEN GD, CHINA
The supplier contact number: +86-755-86655561
Amphaster Nanjing Pharmaceuticals Inc
Category: APIs > Bio Products
Product: Fluticasone propionate
CAS No: 80474-14-2
Standard: USP
Supplier address: No.5 Xinghe Road, Nanjing Economic and Technological Development Zone, Jiangsu,China
The supplier contact number: +86-25-85807880
Chongqing Huapont Pharmaceutical Co., Ltd.
Chongqing Huapont Pharm is a leading manufacturer in China that is specialized in finished dosage forms (FDFs) and APIs.
Their API facility of Huapont Pharm has become an exporting base of APIs, whereof GMP has been inspected and approved by US-FDA, MEDSAFE, COFEPRIS, other countries authorities, and many customers. Their main sales market includes the USA, Middle East, Europe, etc.
Category: Active Pharmaceutical Ingredients
Product: Fluticasone propionate
CAS No: 80474-14-2
Status: US DMF
Standard: In-house Standards
Supplier address: No.69 Xingguang Avenue, Renhe Town, Yubei District, Chongqing, China 401121
The supplier contact number: +86-23-67886927
11.FAQ:
Is fluticasone propionate a steroid?
Fluticasone propionate is a synthetic steroid that belongs to the glucocorticoid family, which has anti-inflammatory properties.
What does fluticasone propionate nasal spray do?
It works by reducing the inflammation and irritation in the nose cavity caused by conditions such as rhinitis.
References:
https://pubchem.ncbi.nlm.nih.gov/compound/Fluticasone-propionate
https://go.drugbank.com/drugs/DB00588
https://www.ncbi.nlm.nih.gov/books/NBK542161/
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020121s045lbl.pdf
https://www.rxlist.com/flonase-drug.htm
https://www.centurypharma.net/api-products.html
https://www.rxlist.com/cutivate-drug.htm
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021433s015lbl.pdf
https://www.drugs.com/mtm/fluticasone-and-salmeterol.html
https://www.pharmacompass.com/price/fluticasone-propionate
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3147057/
https://www.goodrx.com/blog/flonase-vs-veramyst-whats-the-difference/
https://www.pharmasources.com/
https://www.pharmacompass.com/manufacturers-suppliers-exporters/fluticasone-propionate
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