1.3 Size and optimization of the formulations
All the formulations were developed exclusively on a laboratory scale of
the order of 1 kg maximum. For this reason, scale-up for production must
therefore be checked and revised, as necessary.
It is only in very exceptional cases that the formulations have been opti-
mized by a systematic study involving a comparison between different exci-
pients or by varying the amounts of excipients. Thus, the formulations are
merely suggestions that require fur- ther optimization.
1.4 Active substances
The active substances are almost ex- clusively generic. They were mostly
supplied free of charge as samples by pharmaceutical companies. Since the
manufacturer’s name was mostly not mentioned, it unfortunately cannot be
listed here.
Significant differences in the proper- ties of the preparations may occur if
the same active substance is used, but has a different grain size or origi-
nates from another manufacturer. The reason for this is that the difference in
physical properties may exert a strong effect particularly on solid drugs
cf. Chapter 2.5.
1.5 Excipients
As far as possible, the manufacturer’s name and the registered trademark
are given for excipients. The excipients mostly used in the for-
mulations and their suppliers are list- ed in Table 1. The serial numbers in
the left-hand column of this table are quoted in the formulations.
BASF Fine Chemicals Generic Drug Formulations 1998
Table 1 Supplier and address
Excipients
[1] BASF AG
Cremophor
®
products Department MER
Kollicoat
®
products 67056 Ludwigshafen,
Kollidon
®
products Germany
Ludipress
®
Lutrol
®
products Propylene glycol Pharma
or Sicovit
®
BASF subsidiary in the Soluphor
®
P country concerned
Solutol
®
HS 15 [2]
Bärlocher GmbH Calcium arachinate
80992 Munich, Germany Magnesium stearate
[3] Cerestar GmbH
Düsseldorferstrasse 191 Potato starch
47809 Krefeld, Germany Corn starch
[4] Degussa AG
GB Industry + Fine Chemicals Postfach 1345
63457 Hanau, Germany Aerosil
®
200 [5]
FMC Corp. Food + Pharmaceutical
Products 735 Market Street
Avicel
®
products Philadelphia, PA 19103, USA
Ac-Di-Sol
®
[6] Hüls AG
Postfach 45674 Marl, Germany
Polyethylene glycol 6000, powder [7]
Mallincrodt Inc. P.O. Box 5439
675 McDonnel Boulevard St. Louis, MO 63134, USA
Stearic acid [8]
Meggle Milchindustrie GmbH Postfach 40
Lactose Monohydrate D 20 83512 Wasserburg, Germany
Tablettose
®
BASF Fine Chemicals Generic Drug Formulations 1998
[9] Rhône-Poulenc
15, Rue Pierre Pays B.P. 52
69660 Collonges-au Mont d’ Or, Dicalcium phosphate, CaHPO
4
France DITAB
®
[10] Riedel-de-Haen AG
Wunstdorferstrasse 40 Sorbitol, crystalline
30926 Seelze, Germany Talc
BASF Fine Chemicals Generic Drug Formulations 1998
BASF Fine Chemicals Generic Drug Formulations 1998
1.6 Stability data