US 6,432,438 B1 · Biodegradable vehicle and filler

Abstract

A biodegradable vehicle and filler (referred to in this invention as biodegradable vehicle), which can be mixed with one or more biologically active substances (BAS), or can be used as a biodegradable filler to fill in cavities or body tissues in animals, birds and humans. The consistency and rheology, hydrophilicity and hydrophobicity, and in vivo degradation rates of the biodegradable vehicle is controlled by modulating the molecular weight of polymers and copolymers, concentration of plasticizers, ratios of two or more plasticizer in the blends, types of polymers and copolymers, copolymer ratios, and ratios of blends of polymers with different molecular weights or different copolymers. The biodegradable vehicle is mixed with one or more BAS (which is separately stored away from the biodegradable vehicle in an appropriate container) just prior to use. Mixing of the BAS with the biodegradable vehicle can be accomplished by simply stirring the mixture with a stirring device, or by triturating the mixture or employing an ointment mill or a suitable device or apparatus or equipment that can be used for blending/mixing. Alternatively, a device, which resembles two syringes, attached together with a removable partition or a valve assembly can also be used to uniformly mix the BAS with the biodegradable vehicle. The mixing is performed in order to dissolve or uniformly suspend the BAS particles in the biodegradable vehicle. Modulating the polymer to plasticizer ratio, polymer molecular weight, copolymer ratio, and hydrophobicity and hydrophilicity of the plasticizer controls the release of the BAS from the biodegradable vehicle.

Claims68

Dependent claims

A method for the formulation of a biodegradable system comprising mixing:

(a) at least one biodegradable polymer or copolymer, said polymer or copolymer selected from the group consisting of homopolymers or copolmers of polyesters, polyorhoesters, polylactides, polyglycolides, polycaprolactones, polyhydroxybutyrates, polyhydroxyvalerates, polyamino acids, pseudopolyamino acids, polyamides and polyanhydrides;
(b) at least two plasticizers, wherein at least one plasticizer is hydrophilic and at least one plasticizer is hydrophobic;
and
(c) at least one biologically active substance;
to produce a biologically active substance-loaded biodegradable vehicle.

2 more elements

A method for enhancing the stability of the formulation of a biodegradable system comprising mixing:

(a) at least one biodegradable polymer or copolymer, said polymer or polymer selected from the group consisting of homopolymers or copolymers of polyesters, polyorthoesters, polylactides, polyglycolides, polycaprolactones, polyhydroxybutyrates, polyhydroxyvalerates, porno acids, pseudopolyamino acids, polyamides and polyanhydrides;
(b) at leas two plasticizers, wherein at least one plasticizer is hydrophilic and at least one plasticizer is hydrophobic;
and
(c) at least one biologically active substance;
to produce a biologically active substance-loaded biodegradable vehicle.

2 more elements

A method for modulating the release characteristics of the biologically active substance in the formulation of a biodegradable system comprising mixing:

(a) at least one biodegradable polymer or copolymer, said polymer or copolymer selected from the group consisting of homopolymers or copolymers of polyesters, polyorthoesters, polylactides, polyglycolides, polycaprolactones, polyhydroxybutyrates, polyhydroxyvalerates, polyamino acids, pseudopolyamino acids, polyamides and polyanhydrides;
(b) at least two plasticizers, wherein at least one plasticizer is hydrophilic and at least one plasticizer is hydrophobic;
and
(c) at least one biologically active substance;
to produce a biologically active substance-loaded biodegradable vehicle.

2 more elements

A method for modulating the dose of a bioactive agent in the formulation of a biodegradable system comprising mixing:

(a) at least one biodegradable polymer or copolymer, said polymer or copolymer selected from the group consisting of homopolymers or copolymers of polyesters, polyorthoesters, polylactides, polyglycolides, polycaprolactones, polyhydroxybutyrates, polyhydroxyvalerates, polyamino acids, pseudopolyamino acids, polyamides and polyanhydrides;
(b) at least two plasticizers, wherein at least one plasticizer is hydrophilic and at least one plasticizer is hydrophobic;
and
(c) at least one biologically active substance;
to produce a biological active substance-loaded biodegradable vehicle.

2 more elements

A method for modulating the consistency or rheology of the formulation of a biodegradable system comprising mixing:

(a) at least one biodegradable polymer or copolymer, said polymer or copolymer selected from the group consisting of homopolymers or copolymers of polyesters, polyorthoesters, polylactides, polyglycolides, polycaprolactones, polyhydroxybutyrates, polyhydroxyvalerates;
polyamino acids, pseudopolyamino acids, polyamides and polyanhydrides;
(b) at least two plasticizers, wherein at least one plasticizer is hydrophilic and at least one plasticizer is hydrophobic;
and
(c) at least one biologically active substance;
to produce a biologically active substance-loaded biodegradable vehicle.

3 more elements

A method for modulating the hydrophilicity or hydrophobicity of the formulation of a biodegradable system comprising mixing:

(a) at least one biodegradable polymer or copolymer, said polymer or copolymer selected from the group costing of homopolymers or copolymers of polyesters, polyorthoesters, polylactides, polyglycolides, polycaprolactones, polyhydroxybutyrates, polyhydroxyvalerates, polyamino acids, pseudopolyamino acids, polyamides and polyanhydrides;
(b) at least two plasticizers, wherein at least one plasticizer is hydrophilic and at least one plasticizer is hydrophobic;
and
(c) at least one biologically active substance;
to produce a biologically active substance-loaded biodegradable vehicle.

2 more elements

A method for modulating the degradation of the formulation of a biodegradable system comprising mixing:

(a) at least one biodegradable polymer or copolymer, said polymer or copolymer selected from the group consisting of homopolymers or copolymers of polyesters, polyorthoesters, polylactides, polyglycolides, polycaprolactones polyhydroxybutyrates, polyhydroxyvalerates, polyamino acids, pseudopolyamino acids, polyamides and polyanhydrides;
(b) at least two plasticizers, wherein at least one plasticizer is hydrophilic and at least one plasticizer is hydrophobic;
and
(c) at least one biologically active substance;
to produce a biologically active substance-loaded biodegradable vehicle.

2 more elements

Dependencies are inferred from the claim text.

Biodegradable vehicle and filler

Life of this patent

Biodegradable vehicle and filler

Life of this patent

Abstract

Claims68