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Properties of Spray-freeze-dried Products and their Characterization
Published in S. Padma Ishwarya, Spray-Freeze-Drying of Foods and Bioproducts, 2022
In an earlier study by Rogers et al. (2003), the authors used a USP 24 Type II Apparatus for the dissolution testing of spray-freeze-dried danazol. Danazol is an orally administered synthetic androgen used in the treatment of endometriosis, fibrocystic breast disease and hereditary angioedema (Brayfield, 2013; Morton & Hall, 2012). About 10 mg of SFD powder containing 4 mg of the active ingredient, Danazol was placed into 900 mL of dissolution media that was prepared by dissolving 150 g of sodium lauryl sulfate (SLS) and 242 g of tris(hydroxymethyl) aminomethane (Tris) in approximately 18 L of purified water. The pH of dissolution media was adjusted to 9.0 with 1 N HCl. Under constant stirring, its volume was made up to 20 L with purified water. The dissolution test was conducted at a constant paddle speed and bath temperature of 50 rpm and 37°C, respectively. Sink condition of the drug was maintained throughout the duration of dissolution testing. Intermittently, 5 mL of samples were collected at the 2nd, 5th, 10th, 20th, 30th and 60th min, using an autosampler and the percentage of dissolved API (danazol) was estimated using HPLC. Thus, this study determined dissolution according to the first definition mentioned in the beginning of Section 10.3.1.
Biomanufacture
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Rabbits have also been used as a reliable and efficient source of a clotting factor for a rare blood disorder. In this case, a transgenic rabbit is created as a bioreactor, and a C1 esterase inhibitor, produced in the milk of transgenic rabbits, is licensed for the treatment of hereditary angioedema. A lactating rabbit can produce 10–12 g of protein per liter of milk, whereas traditional methods of protein expression from cell culture systems are less efficient, with yields ranging from 0.2 to 1.0 g of protein per liter of culture media. These are just a couple of examples where cutting-edge biotechnology has demonstrated the proof of concept and then has been successfully developed to reach the marketplace.
Drug-induced acute upper airway obstruction
Published in Philippe Camus, Edward C Rosenow, Drug-induced and Iatrogenic Respiratory Disease, 2010
Michael Lippmann, Ganesan Murali
The hypothesized mechanism of ACEI angioedema is the inhibition of bradykinin degradation by the drug, which acts as a kininase II inhibitor, as kininase II is identical to angiotensin-converting enzyme. The resulting increase in circulating bradykinin leads to a vasodilatory state, altering capillary permeability and leading to oedemagenesis, increased postcapillary venule pressure with the release of other vasoactive peptides.2,21 In addition there may be genetic factors such as a deficiency of other bradykinin-metabolizing enzymes such as carboxypeptidase-N and aminopeptidase-P.13 Nussberger et al. measured bradykinin levels in patients with hereditary angioedema, acquired angioedema, and one patient with angioedema due to captopril.37 Levels all rose during an acute attack of angioedema in all conditions, with the level rising 15-fold in the ACEI-induced cases, falling back to normal after drug withdrawal. In a subsequent paper the same authors described four additional patients with ACEI-induced angioedema, three of whom had elevated bradykinin levels during remission.16,38 Anderson and deShazo studied the cutaneous wheal and flare response to bradykinin, histamine and codeine in 10 normal subjects following the ingestion of the ACEI captopril.39 Five of the 10 patients developed flushing after the bradykinin skin test. They concluded that inhibition of bradykinin metabolism by ACEI is the cause of angioedema and not substance P where an expected increase in wheal and flare to histamine and codeine would have occurred. All these studies support the proposed mechanism of ACEI-induced angioedema outlined in Fig. 7.1.
Combined microfluidics and drying processes for the continuous production of micro-/nanoparticles for drug delivery: a review
Published in Drying Technology, 2023
Ankit Patil, Pritam Patil, Sagar Pardeshi, Preena Shrimal, Norma Rebello, Popat B. Mohite, Aniruddha Chatterjee, Arun Mujumdar, Jitendra Naik
The challenges faced in drug delivery are physical properties of drug-like low solubility, low bioavailability, non-uniform particle size distribution, and crystalline nature of the particle. The formulation development by spray drying possesses some limitations, like a single solvent system or a mixture of solvents in a single phase. The limitation can be overcome by using an additional setup. In this context, researchers used a microreactor with two flows focusing on cross junctions whose outlet is connected to the spray dryer inlet to achieve continuous operation that allows efficient processing of solvent antisolvent mixture. In this, they have developed nanoparticles of the hydrophobic drug (Danazol) used to treat endometriosis and hereditary angioedema. In the first step, they dissolved the drug in IPA (solvent) and injected it with antisolvent (water) at the first cross-section. The microfluidic operation allows diffusion-based mixing of the solvent and antisolvent phase at the interface. The solvent-to-antisolvent ratio was kept at 1:10. The solvent flow was maintained at 5 mL h−1, while the antisolvent was kept at 50 mL h−1. The obtained feed is spray-dried to get free-flowing powder. The obtained nanoparticles size was in the range of 20-60 nm, whereas the pure drug size was 2-100 µm. The microreactor allowed efficient mixing of drug solution with antisolvent that confirms the drug solution supersaturation governs the nucleation process and yields nanoparticles. The researcher also studied the effect of distance from the spraying nozzle to the collection chamber. In the first case, the distance was kept at 5 cm, which gives assemblies of stacks of Danazol. In this, each stack thickness was found to be 60–80 nm (Figure 5a). To increase the time of flight for complete evaporation of the solvent; the distance was increased up to 30 cm that yielding densely packed nanoparticles (Figure 5b). The XRD pattern of both formulations showed that as the collection distance increases, the intensity of characteristic peaks decreases result in more amorphous powder (Figure 5c).[190]