1. A process for the preparation of a crystalline polymorph of 1-(2-dimethylamino)-1-(4-methoxyphenyl)ethylcyclohexanol hydrochloride which exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in d-values (\u212b) at
15.3 (vw), 11.9 (w), 9.6 (w), 9.1 (vw), 8.1 (vw), 7.7 (w), 6.3 (vw), 6.0 (m), 5.92 (m), 5.55 (m), 5.46 (vw), 5.20 (m), 5.00 (w), 4.91 (vw), 4.77 (m), 4.57 (s), 4.49 (s), 4.31 (s), 4.26 (s), 4.04 (vw), 3.98 (vw), 3.90 (vw), 3.82 (w), 3.68 (vw), 3.60 (w), 3.52 (w), 3.45 (vw), 3.33 (m), 3.29 (m), 3.22 (vw), 3.15 (vw), 3.07 (vw), 2.87 (vw), 2.81 (w), 2.72 (vw), 2.58 (vw), 2.51 (vw), 2.49 (vw), 2.43 (vw), 2.35 (vw):
wherein (s)=strong intensity; (m)=medium intensity; (w)=weak intensity; and (vw)=very weak intensity, which comprises dissolving Venlafaxine in an organic solvent to form a solution at elevated temperature, adding seeding crystals, cooling the solution, and separating the crystalline polymorph.
2. A process according to claim 1, wherein the seeding crystals are ground before addition to the solution.
3. A process for the preparation of the crystalline polymorph defined in claim 1, which comprises equilibrating a slurry of polymorphic Form C in isopropanol and separating the crystalline polymorph defined in claim 1.
4. A process for the preparation of a crystalline polymorph of 1-(2-dimethylamino)-1-(4-methoxyphenyl)ethylcyclohexanol hydrochloride which exhibits a characteristic X-ray powder diffraction pattern with characteristic peaks expressed in d-values (\u212b) at
11.7 (s), 10.2 (w), 7.7 (vw), 6.8 (m), 5.90 (vs), 5.67 (w), 5.57 (vw), 5.37 (m), 5.04 (w), 4.91 (vw), 4.76 (m), 4.70 (m), 4.53 (w), 4.47 (w), 4.42 (vw), 4.32 (m), 4.14 (m), 4.10 (w), 3.95 (vw), 3.84 (w), 3.77 (vw), 3.68 (w), 3.60 (vw), 3.50 (w), 3.35 (m), 3.28 (w), 3.15 (w), 3.07 (vw), 3.04 (vw), 3.01 (vw), 2.93 (w), 2.84 (w), 2.77 (vw), 2.72 (w), 2.68 (vw), 2.63 (w), 2.59 (w), 2.46 (vw), 2.37 (vw), 2.35 (vw), 2.31 (vw), 2.27 (vw), 2.26 (vw); wherein (vs)=very strong intensity; (s)=strong intensity; (m)=medium intensity; (w)=weak intensity; and (vw)=very weak intensity, which comprises evaporating or lyophilisation of an aqueous solution of 1-(2-dimethylamino)-1-(4-methoxyphenyl)ethylcyclohexanol hydrochloride.
5. A process according to claim 1, wherein the organic solvent is isopropanol.
6. A process according to claim 1, wherein the quantity of seeding crystals is 2 to 10% of the quantity of Venlafaxine hydrochloride.
7. A process according to claim 1, wherein the seeding crystals are added within a metastable zone 1 to 10\xb0 C. below the temperature of complete dissolution.
8. A process according to claim 1, wherein the elevated temperature is 40 to 80\xb0 C.
9. A process according to claim 1, wherein cooling rate is 0.1 to 2\xb0 C. per minute.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A humeral prosthesis for fitting to a humerus in a shoulder joint arthroplasty procedure, the prosthesis comprising:
a first body having a first body articulating surface defining a generally circular outer periphery and a first centerline axis, the first body having (a) a support surface opposite to the first body articulating surface such that the first body is hollow and configured to receive a head of the humerus, and (b) a stem extending away from the support surface configured to assist in securing the prosthesis on the humerus, the stem defining a second centerline axis which is coincident with the first centerline axis; and
a second body in the form of a flange which extends laterally from a portion of the circular outer periphery of the first body articulating surface, in which the first body articulating surface and a surface of the second body define a boundary portion between them which is generally smooth and continuous, wherein the second body is located superiorly and the surface of the second body which bounds the first body articulating surface is a second articulating surface.
2. The prosthesis of claim 1, in which the first body is generally hemispherical.
3. The prosthesis of claim 1, in which the second body is a sector of a hollow sphere.
4. The prosthesis of claim 1, in which the first body and the second body are generally in the shape of a sector of a hollow sphere.
5. The prosthesis of claim 1, in which the second surface defines a second surface periphery opposed to the first body, in which the generally circular outer periphery defines a first plane, and in which the second surface periphery defines a second plane, the first plane and the second plane being non-coincident.
6. A kit for use in resurfacing a humeral head, comprising:
a prosthesis comprising
a first body having a first body articulating surface defining a generally circular outer periphery and a first centerline axis, the first body having (a) a support surface opposite to the first body articulating surface such that the first body is hollow and configured to receive a head of the humerus, and (b) a stem extending away from the support surface configured to assist in securing the prosthesis on the humerus, the stem defining a second centerline axis which is coincident with the first centerline axis, and
a second body in the form of a flange which extends laterally from a portion of the circular outer periphery of the first body articulating surface, in which the first body articulating surface and a surface of the second body define a boundary portion between them which is generally smooth and continuous, wherein the second body is located superiorly and the surface of the second body which bounds the first body articulating surface is a second articulating surface;
a reamer for preparing a first prepared surface on the humerus for receiving the support surface on the first body which is opposite to the first body articulating surface; and
a bone cutting tool for preparing a second prepared surface on the humerus for receiving a second support surface which is provided by the second body opposite to the second body articulating surface.