Controlled release of pharmacologically active agents from an absorbable biologically compatible putty-like composition

• US 4,568,536 A
• Filed: 02/08/1985
• Issued: 02/04/1986
• Est. Priority Date: 02/08/1985
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Kronenthal, Richard L., Mattei, Frank V., Levy, Alan J.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/687,692
• Time in Patent Office: 361 Days
• Field of Search: 424/19, 424/22, 514/772, 514/777, 514/784, 514/785, 514/900, 514/902, 514/953, 514/960, 514/964, 514/965, 514/969
• US Class Current: 424/435
• CPC Class Codes: A61K 9/0063 Periodont
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/205 Polysaccharides, e.g. alginate, gums; Cyclodextrin

Abstract

An absorbable biologically compatible putty-like composition is used as a matrix from which immunologically or pharmacologically active agents, such as antibiotics, can be introduced into the body to provide a slow sustained release of the agent over an extended period of time. A preferred matrix comprises a mixture of calcium stearate, dextran and castor oil.

Claims

1. In a peridontal desease gum treating method for administration of at least one pharmacologically or immunologically active agent released slowly over an extended period of time to infected or target area pockets between the base of a tooth and the adjoining periodontal tissues, which comprises a combination of

(a) from 0.25% to 50% by weight of the composition of a pharacologically or immunologically active agent in an effective depot amount greater than the single dose amount, and (b) a matrix which is minimally reactive towards body tissue and which is absorbable in the body over an extended period of time without adverse body reaction;

the improvement comprising employing as said matrix dispensed in the shape of a rod, pellet, disc or tiny gum drop, to a pocket formed by teasing the gum away from the tooth an absorbable composition comprising;

(i) a component (A) comprising a mixture of calcium stearate and dextran in which said mixture comprises between about 35% and about 60% by weight of said calcium stearate based on the weight of the matrix and between about 10% and about 35% by weight of dextran, based on the weight of the matrix; and

the remainder of the matrix comprising

(ii) a component (B) comprising a biocompatible base consisting of a natural or synthetic oil or wax which is absorbable in the body,

said composition having a putty-like consistency at room and body temperatures.

2. The method of claim 1 in which component (B) is selected from the group consisting of sesame oil, sweet almond oil, castor oil, cottonseed oil, olive oil, cod liver oil, safflower oil, soya oil, peanut oil and corn oil.

3. In a periodontal disease gum treating method for administration of at least one pharmacologically or immunologically active agent released slowly over an extended period of time to infected or target area pockets between the base of a tooth and the adjoing periodontal tissues, which comprises a combination of

(a) from 0.25% to 50% by weight of the composition of a pharmacologically or immunologically active agent in an effective depot amount greater than the single dose amount, and

(b) a matrix which is minimally reactive towards body tissue and which is absorbable in the body over an extended period of time without adverse body reaction;

the improvement comprising employing as said matrix dispensed in the shape of a rod, pellet, disc or tiny gum drop, to a pocket formed by teasing the gum away from the tooth an absorbable composition comprising between about 35% and about 45% by weight of calcium stearate, between about 10% and about 35% by weight of dextran, the remainder of said matrix comprising castor oil.

4. The method of claim 3, wherein said matrix comprises about 41 weight percent of calcium stearate, about 30 weight percent dextran and about 29 weight percent castor oil.