see Chapter 4 illustrate the use of Kollidon CL-M.
C Lutrol F products The polyoxamers, Lutrol F 68 and
Lutrol F 12 7, in concentrations of 2 – 5 , expressed in terms of the
final weight of the suspension, of- fer a further opportunity of stabiliz-
ing suspensions. They also do not increase the viscosity when used in
these amounts and can be com- bined with all other conventional
suspension stabilizers.
5.3.2 Parenteral suspensions
Kollidon 17 PF is eminently suitable for improving the wetability of the
active substance in parenteral sus- pensions, e.g. penicillin ampoules. It
reduces the sedimentation rate and improves the dispersability. Kollidon
17 PF, in the amounts used for this purpose, exerts practically no influ-
ence on the viscosity.
Solutol HS 15 can also be used.
5.3.3 Dispersions for tablet coating
Kollidon 25 or Kollidon 30 are particu- larly suitable for stabilizing pigment
suspensions. Examples are given in Chapter 3.4.
5.4 Aromas and dyes
Aromas and dyes are quoted in only exceptional cases, because they
depend strongly on the taste of the target group concerned and are often
specific for a particular country. They can be included in the formulations if
this is wished.
5.5 Preservation
In a few cases, preservatives have been already integrated in the formu-
lations. In difficult cases, e.g., antiac- id suspensions with a pH more than
7, the preservative system i.e. bacte- ria-free or low-bacteria production,
should be the subject of accurate re- search.
BASF Fine Chemicals Generic Drug Formulations 1998
100 80
60 40
20 Kollidon CL-M
Crospovidone M R
el at
iv e
se d
im en
t vo
lu m
e af
te r
2 4
h ,
Fig. 5 Volume of sediment of various micronized crospovidone types 7.5 in water + 5 Lutrol F 127
5.6 Physical stability
The most important parameters for the physical stability of suspensions
are the relative volume of sediment = volume of sediment total volume
and the redispersability. They are tested after 1 – 4 weeks have elapsed.
5.7 Chemical stability
Data on the chemical stability at room temperature have been compiled al-
most exclusively for vitamins. A stress test was almost always performed for
PVP-iodine preparations, and this corresponds to at least one year at
room temperature.
5.8 Formulations
The formulations mentioned in this chapter are arranged in alphabetical
order of their active substances.
BASF Fine Chemicals Generic Drug Formulations 1998
BASF Fine Chemicals Generic Drug Formulations 1998
6 Semi-solid drugs gels,
creams, suppositories
and ovula
6.1 Size of formulations and amounts used
The formulations were developed on a laboratory scale.
The size of the batch was usually 100 g, with the result that care must
be exercised in scaling up from a laboratory to a production scale.
6.2 Emulsifying agents in pharma- ceutical creams
The Cremophor types, Cremophor A 6 and Cremophor A 25 are the most
suitable in the BASF line of excipients for the development of macroemul-
sions with the appearance and the consistency of a cream. They allow
the production of physically stable formulations when they are used in
low concentrations in the vicinity of 1 – 4 .
6.3 Excipients as a base for suppositories and ovula
