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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No indication of GLP and study with patches

Data source

Reference
Reference Type:
publication
Title:
Effect of Transdermally Delivered Aspirin on Blood Coagulation Parameters
Author:
Shamsher, A.A. et al.
Year:
2010
Bibliographic source:
American Journal of Biomedical Sciences 2(2), 129-141

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 427 (Skin Absorption: In Vivo Method)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solvant

Test animals

Species:
human

Administration / exposure

Vehicle:
other: lemon oil and turpentine
Duration of exposure:
24 hours

Results and discussion

Signs and symptoms of toxicity:
no effects
Dermal irritation:
no effects
Absorption in different matrices:
no more than 1%

Applicant's summary and conclusion

Conclusions:
It is clearly shown on rat or human skin that ASA do not penetrated more than 1 or 2% without a vehicle
Executive summary:

The feasibility of delivering aspirin transdermally from eudragit and polyvinyl acetate (PVA) matrix-type patches to enhance its antithrombotic efficiency of aspirin was investigated. Transdermal films containing mixture of eudragit RL: eudragit RS and polyvinyl acetate were fabricated. Eudragit RL: eudragit RS (5:1) films containing 30 mg/ transdermal patch aspirin showed maximum release (11.891.1g/cm2) after 24 hrs as compared to PVA films. With regards to appearance eudragit films were also wrinkle free, uniform, flexible and transparent with good adhesion property to skin. The effect of turpentine oil and lemon oil at different concentrations on the in vitro percutaneous absorption of aspirin from eudragit copolymer patches through rat skin was investigated. Two formulation containing 50 mg/transdermal patch ASA with 0.042 ml turpentine oil and 0.042 ml lemon oil showed a significantly higher flux of ASA 4.22 g/cm2/hr and 38.52 g/cm2/hr respectively. The optimized formulations influenced the blood coagulation parameters (bleeding time, prothrombin time, Activated partial prothrombin time) significantly by means of affecting both the extrinsic coagulation system and the intrinsic coagulation system as compared to orally administered and control gel formulations.