Chemistry Reference
In-Depth Information
would set out an inventive dispersion of an amorphous API in a class of generic
polymers.
In other amorphous dispersions, it may be that one matrix material or a particular
combination of matrix materials could be found to disperse and stabilize a class of APIs.
Here the inventive dispersion is for a genus of amorphous APIs dispersed within a
speci
cation would describe the APIs by their common
features, perhaps by way of a general structural formula, and the method by which they
may be dispersed within the matrix material.
Another common variant for amorphous sold dispersions is the range of relative
amounts of the API and the polymer matrix that yield successful dispersions. See claim 2
of the sample claim set, “A solid dispersion of claim 1, wherein the weight ratio of drug to
polymer matrix ranges from about 20:80 to about 5:95.
c matrix material. The speci
To claim amorphous solid
dispersions of a generic class of amorphous APIs and/or a generic class of matrix
materials, the speci
”
cient supporting disclosure to satisfy the
enablement requirement. This is typically done with a full description of each component
of the invention and then examples showing speci
cation must contain suf
c embodiments with different weight
ratios as part of the broader description.
While the expositive discussion of the detailed description supports the invention by
describing its various aspects, the working examples of the invention come at it from the
other side. The working examples are often speci
c examples describing the actual
preparation of amorphous solid dispersion(s) according to the invention, characterization
of the amorphous solid dispersion(s) by one ormore analytical techniques, and tests to show
the properties of the amorphous solid dispersion(s). A typical example set may be outlined
as indicated below (with the normal experimental discussion omitted). The example set may
contain preparative examples, characterization examples and formulation examples.
Examples
Description of analytical
techniques used (e.g., XRPD and DSC methods and
parameters).
Example 1: Preparation of an amorphous solid dispersion.
Example 2: Characterization of an amorphous solid dispersion.
2.1 XRPD characterization with its XRPD pattern shown in Figure X.
2.2 DSC characterization with a reported
T
g
and DSC pattern in Figure Y.
Example 3: Stability testing of the amorphous solid dispersion(s).
Example 4: Dissolution testing of the amorphous solid dispersion(s).
Example 5: Pharmaceutical composition containing the amorphous solid dispersion.
The example set may contain preparative and characterization examples, etc., for a
representative number of amorphous solid dispersions of the invention in order to show the
variation and breadth of the claimed invention. The additional examples could vary the
relative amounts of API and polymer matrix in the dispersions, include additional
components to the amorphous solid dispersions, report different techniques to prepare
amorphous sold dispersions, show different APIs, and show that different polymers within
a class or a mixture of polymers may be used. For pharmaceutical inventions, the examples
