Use of a human amniotic membrane composition for prophylaxis and treatment of diseases and conditions of the eye and skin

• US 20080108045A1
• Filed: 10/25/2007
• Published: 05/08/2008
• Est. Priority Date: 09/18/2002
• Status: Active Grant

• Current Assignee: Repsco LLP
• Original Assignee: Repsco LLP
• Inventors: Ghinelli, Emiliano
• Granted Patent: US 7,871,646 B2
• Time in Patent Office: Days
• US Class Current: 435/1.3
• CPC Class Codes: A61K 35/48 Reproductive organs

Abstract

A method of preparing an amniotic membrane extract including the steps of obtaining a healthy amniotic membrane from a pregnant mammal, such as a pig, cow, horse or human, homogenizing the membrane to obtain a homogenate solution, freezing the homogenate solution, and lyophilizing the frozen homogenate solution to dryness is disclosed. Preferably, the lyophilized homogenate is pulverized to a powder. The lyophilized homogenate is then reconstituted before use, e.g., in a liquid, such as a balanced salt solution or fresh amniotic fluid, or in another substance, such a gel, an ointment, a cream or a soap, depending on the intended use. Also disclosed is a pharmaceutical composition prepared according to the method of the invention, for prophylaxis and/or treatment of a disease or condition, especially of the eye or the skin. Exemplary pharmaceutically acceptable carriers for the composition of the invention include an ophthalmic solution for eye drops, a gel, an ointment, an emulsion, a cream, a powder and a spray.

Claims

1. A method of preparing a mammalian amniotic membrane extract, said method consisting essentially of carrying out in the order given the steps of:

a) obtaining a healthy amniotic membrane from a pregnant mammal;

b) homogenizing said membrane to obtain a homogenate solution;

c) centrifuging said homogenate solution and removing the homogenate supernatant, wherein steps a, b and c are all carried out at 4°

C.;

d) quick-freezing said homogenate supernatant; and

e) lyophilizing said frozen homogenate supernatant to dryness to obtain said mammalian amniotic membrane extract.

2. The method of claim 1, further comprising the step of processing said lyophilized homogenate supernatant to a powder.

3. The method of claim 1, further comprising the step of reconstituting said lyophilized homogenate supernatant.

4. The method of claim 3, wherein said lyophilized homogenate supernatant is reconstituted in a liquid.

5. The method of claim 4, wherein said liquid is selected from the group consisting of balanced salt solution and fresh amniotic fluid.

6. The method of claim 3, wherein said lyophilized homogenate supernatant is reconstituted in a gel, an ointment, a cream or a soap.

7. The method of claim 1, wherein said amniotic membrane is a human amniotic membrane.

8. The method of claim 1, wherein said amniotic membrane is obtained from a mammal selected from the group consisting of pig, cow and horse.

9. The method of claim 1, wherein said amniotic membrane is freshly obtained.