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Isotretinoin INN Pharmaceutical Intermediates
Isotretinoin INN Pharmaceutical Intermediates

Isotretinoin INN Pharmaceutical Intermediates

Contact : Mr.Thyen------------------------------- Email us at zhangyinglong@ycphar.com Whatsapp : +86 180 3817 6818

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Isotretinoin (INN)


Contact : Mr.Thyen

Email us at zhangyinglong@ycphar.com

Whatsapp : +86 180 3817 6818


Abstract

Isotretinoin (INN), also known as 13-cis retinoic acid, is an oral pharmaceutical drug primarily used to treat cystic acne. Rarely, it is also used to prevent certain skin cancers (squamous-cell carcinoma), and in the treatment of other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Its isomer, tretinoin, is also an acne drug.
Isotretinoin is primarily used as a treatment for severe acne. The most common adverse effects are a transient worsening of acne (lasting 2-3 weeks), dry lips (cheilitis), dry and fragile skin, and an increased susceptibility to sunburn. Uncommon and rare side effects include: muscle aches and pains (myalgias), and headaches. Isotretinoin is known to cause birth defects due to in utero exposure because of the molecule's close resemblance to retinoic acid, a natural vitamin A derivative which controls normal embryonic development.

 

Specification

Product name

Isotretinoin (13-cis Vitamin A acid)

CAS No.

4759-48-2

Packing

100G/25KG

Date of manufacturing

2th, July, 2016

Shelf life

1th, July, 2018

Standard

USP34

ITEMS

SPECIFICATION

RESULTS

Appearance

Yellow or orange crystalline powder

Complies

Identification

Complies

Complies

Loss on drying

Not more than 0.5%

0.05%

Residue on ignition

Not more than 0.1%

0.02%

Heavy metals

Not more than 0.002%

<0.002

Tretinoin

Not more than 1.0%

0.1%

Assay

98%~102.0%

99.8%

Conclusion

Qualified



Function

1.Isotretinoin's main indication is for the treatment of severe cystic acne vulgaris. Many dermatologists also support its use for treatment of lesser degrees of acne that prove resistant to other treatments, or that produce physical or psychological scarring.
2.It is also somewhat effective for hidradenitis suppurativa and some cases of severe acne rosacea. It can also be used to help treat harlequin ichthyosis, lamellar ichthyosis and is used in xeroderma pigmentosum cases to relieve keratoses. Isotretinoin has been used to treat the extremely rare condition fibrodysplasia ossificans progressiva. It is also used for treatment of neuroblastoma, a form of nerve cancer.
3.Isotretinoin therapy has furthermore proven effective against genital warts in experimental use, but is rarely used due to potentially severe side effects. In a small-scale study, low dose oral isotretinoin showed considerable efficacy;
4.Isotretinoin may represent an efficacious and safe alternative systemic form of therapy for RCA of the cervix. Not many studies have been conducted to further confirm its effectiveness. In most countries this therapy is currently unapproved and only used if other therapies failed.

 

Medical uses
Isotretinoin is used primarily for severe cystic acne and acne that has not responded to other treatments.Many dermatologists also support its use for treatment of lesser degrees of acne that prove resistant to other treatments, or that produce physical or psychological scarring.
It is also somewhat effective for hidradenitis suppurativa and some cases of severe acne rosacea.It can also be used to help treat harlequin ichthyosis, lamellar ichthyosis and is used in xeroderma pigmentosum cases to relieve keratoses. Isotretinoin has been used to treat the extremely rare condition fibrodysplasia ossificans progressiva. It is also used for treatment of neuroblastoma, a form of nerve cancer.
Isotretinoin therapy has furthermore proven effective against genital warts in experimental use, but is rarely used for this indication as there are more effective treatments. Isotretinoin may represent an efficacious and safe alternative systemic form of therapy for RCA of the cervix. In most countries this therapy is currently unapproved and only used if other therapies failed.


Mechanism of Action
Isotretinoin is the only therapy that impacts on all of the major aetiological factors implicated in acne. It achieves this remarkable efficacy by influencing cell-cycle progression, cellular differentiation, cell survival and apoptosis.1-7 It results in a significant reduction in sebum production, influences comedogenesis, lowers surface and ductal P. acnes and has anti-inflammatory properties.

A dose of 0.5-1.0 mg/kg/day dramatically reduces sebum excretion by the order of 90% within 6 weeks. Unlike tretinoin (all-trans retinoic acid), isotretinoin has little or no ability to bind to cellular retinol-binding proteins or retinoic acid nuclear receptors (RARs and RXRs) but may act as a pro-drug that is converted intracellularly to metabolites that are agonists for RAR and RXR nuclear receptors.

 

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