Manufacture of long term contraceptive implant

Claim 2

The process of preparing a fused implant for fertility control which comprises the steps of: (a) purifying an anti-ovulation sex hormone; (b) storing the purified anti-ovulation sex hormone (c) loading a finely divided mixture of pure anti-ovulation sex hormone and a pure lipoid carrier into a tube of a suitable diametermade from a flexible inert plastic having a non-stick surface; (d) compacting the ingredients in the tube; (e) heating the tube and the contents at a temperature above the melting point of the anti-ovulation sex hormone and the lipoid carrier to fuse the mixture; and (f) allowing the tube to cool, the steps (b)-(f) being conducted in an inert atmosphere and under aseptic conditions.

Claim 3

The process for preparing a fused implant as described in claim 1 wherein the cooled tube and contents are sealed in a glass ampule under inert atmosphere for storage.

Claim 4

The process as described in claim 1 wherein the tubing has an ellipsoidal cross section and is made from a polytetrafluoroethylene type resin.

Claim 5

The process as described in claim 1 wherein the tube and the contents are heated at a temperature 5°-10° C. above the melting point of the anti-ovulation sex hormone.

Claim 6

The process as described in claim 4 wherein the tube and contents are heated on a metal block for 45-60 seconds.

Claim 7

The process as described in claim 4 wherein the tube and contents are heated in an oil bath for 1.5-2 minutes.

Claim 8

The process of preparing a fused implant for fertilitty control which comprises the steps of: (a) purifying an anti-ovulation sex hormone; (b) storing the purified anti-ovulation sex hormone under nitrogen; (c) loading a mixture of finely divided pure anti-ovulation sex hormone and a finely divided pure lipoid carrier into a piece of tubing of suitable diameter made from a flexible inert plastic having a non-stick surface, fitted with a solid probe at one end; (d) placing a second solid probe in the open end of the tube and moving the two probes toward the solid; (e) heating the piece of tubing at a temperature above the melting point of the anti-ovulation sex hormone and the lipoid carrier to fuse the mixture; (f) moving the two probes to consolidate anti-ovulation sex hormone and carrier; (g) allowing the tube to cool; (h) removing the probes; and (i) storing the tube with the implant enclosed in a glass ampule, the steps (c)-(i) being conducted in a nitrogen atmosphere and under aseptic conditions.

Claim 9

The process of preparing a fused implant for fertilitty control which comprises the steps of: (a) purifying an anti-ovulation sex hormone; (b) storing the purified anti-ovulation sex hormone under nitrogen; (c) loading a mixture of finely divided pure anti-ovulation sex hormone and a finely divided pure lipoid carrier into a piece of tubing of suitable diameter made from a flexible inert plastic having a non-stick surface, fitted with a solid probe at one end; (d) placing a second solid probe in the open end of the tube and moving the two probes toward the solid; (e) heating the piece of tubing at a temperature above the melting point of the anti-ovulation sex hormone and the lipoid carrier to fuse the mixture; (f) moving the two probes to consolidate anti-ovulation sex hormone and carrier; (g) allowing the tube to cool; (h) removing the probes; and (i) storing the tube with the implant enclosed in a glass ampule, the steps (c)-(i) being conducted in a nitrogen atmosphere and under aseptic conditions.

Claim 10

The process as described in claim 7 wherein the tubing has an ellipsoidal cross section and is made from a polytetrafluoroethylene type resin.

Claim 11

The process as described in claim 7 wherein the tube is heated at a temperature 5-10° C. above the melting point of the anti-ovulation sex hormone.

Claim 12

The process as described in claim 1 wherein the tube and contents are heated on a metal block for 45-60 seconds.

Claim 13

The process of preparing a fused implant for fertility control which comprises the steps of: (a) purifying an anti-ovulation sex hormone selected from the group consisting of d-norgestrel, norethindrone and norethindrone acetate; (b) storing the purified anti-ovulation sex hormone under nitrogen; (c) loading a finely divided mixture of pure anti-ovulation sex hormone and a pure lipoid carrier into a tube of a suitable diameter made from a flexible inert plastic having a non-stick surface; (d) compacting the ingredients in the tube; (e) heating the tube and the contents at a temperature above the melting point of the anti-ovulation sex hormone and the lipoid carrier to fuse the mixture; and (f) allowing the tube to cool, the steps (b)-(f) being conducted in an inert atmosphere and under aspetic conditions.

Claim 14

The process of preparing a fused implant for fertility control which comprises the steps of: (a) purifying an anti-ovulation sex hormone selected from the group consisting of d-norgestrel, norethindrone and norethindrone acetate; (b) storing the purified anti-ovulation sex hormone under nitrogen; (c) loading a finely divided mixture of pure anti-ovulation sex hormone and a pure lipoid carrier into a tube of a suitable diameter made from a flexible inert plastic having a non-stick surface; (d) compacting the ingredients in the tube; (e) heating the tube and the contents at a temperature above the melting point of the anti-ovulation sex hormone and the lipoid carrier to fuse the mixture; and (f) allowing the tube to cool, the steps (b)-(f) being conducted in an inert atmosphere and under aspetic conditions.

Claim 15

The process of preparing a fused implant for fertility control which comprises the steps of: (a) purifying an anti-ovulation sex hormone selected from the group consisting of d-norgestrel, norethindrone and norethindrone acetate; (b) storing the purified anti-ovulation sex hormone under nitrogen; (c) loading a mixture of finely divided pure anti-ovulation sex hormone and a finely divided pure lipoid carrier into a piece of tubing of suitable diameter made from a flexible inert plastic having a non-stick surface, fitted with a solid probe at one end; (d) placing a second solid probe in the open end of the tube and moving the two probes toward the solid; (e) heating the piece of tubing at a temperature above the melting point of the anti-ovulation sex hormone and the lipoid carrier to fuse the mixture; (f) moving the two probes to consolidate the anti-ovulation sex hormone and carrier; (g) allowing the tube to cool; (h) removing the probes; and (i) storing the tube with the implant enclosed in a glass ampule, the steps (c)-(i) being conducted in a nitrogen atmosphere and under aseptic conditions.

Claim 16

The process of preparing a fused implant for fertility control which comprises the steps of: (a) purifying an anti-ovulation sex hormone selected from the group consisting of d-norgestrel, norethindrone and norethindrone acetate; (b) storing the purified anti-ovulation sex hormone under nitrogen; (c) loading a mixture of finely divided pure anti-ovulation sex hormone and a finely divided pure lipoid carrier into a piece of tubing of suitable diameter made from a flexible inert plastic having a non-stick surface, fitted with a solid probe at one end; (d) placing a second solid probe in the open end of the tube and moving the two probes toward the solid; (e) heating the piece of tubing at a temperature above the melting point of the anti-ovulation sex hormone and the lipoid carrier to fuse the mixture; (f) moving the two probes to consolidate the anti-ovulation sex hormone and carrier; (g) allowing the tube to cool; (h) removing the probes; and (i) storing the tube with the implant enclosed in a glass ampule, the steps (c)-(i) being conducted in a nitrogen atmosphere and under aseptic conditions.