Abstract: Method for controlling the quality of a freeze-drying process includes the steps of defining a set of experiments by statistical design of experiments; performing freeze-drying processes of a product for each one of the experiments; obtaining a dataset of pressures and temperatures from the freeze dryer, the dataset comprising at least one combined parameter; removing noise intrinsic to the measurements; performing a PCA to obtain a fingerprint of the lyophilization process for each one of the experiments; and selecting a range of fingerprints in which a specific product batch will be within specifications. Also provided is a process for controlling the quality of a freeze-drying process which comprises: performing the freeze-drying process at the temperature and pressure set points of the optimal process; obtaining a fingerprint of the process; and using the range of fingerprints obtained above to assess whether the product batch is within specifications.

Abstract: The present invention relates to a liquid oral pharmaceutical composition of desmopressin, and its use for the treatment of central diabetes insipidus, primary nocturnal enuresis, bleeding in patients with Hemophilia A, with von Willebrand-Jürgens disease and postoperative bleeding.

Abstract: It relates to an oral liquid pharmaceutical composition comprising: a) nifedipine in an amount comprised between 0.1% and 1% w/w; b) ethanol in an amount comprised between 38% and 58% w/w; c) water in an amount comprised between 4% and 12% w/w; d) glycerine in an amount comprised between 30% and 50% w/w; and e) optionally, other pharmaceutical excipients or carriers, the sum total of components being 100% w/w, provided that the composition is substantially free of polyethyleneglycol and derivatives thereof.