Stability repackaging

Repackaging, Relabeling, and Holding of APIs and Intermediates Stability... 

The stability of repackaged pentazocine hydrochloride injection was studied to determine the expiration date. An extrapolation of the Arrhenius plot obtained using 40°, 50°and 60° rate constants gave a k of 5 4-4-8 x 10-5 day- at 25°. This meant that a 10% loss of potency occurred in 1909 days at 25° (4-8). 

Sesin CP, Milette LA, Weiner B. Stability study of 5-fluorouracil following repackaging in plastic disposable syringes. Am J IV Ther Clin Nut 1982 9 23-30. 

Pharmacists are expected to maintain the repackaging facility where the dosage forms are stored and repackaged at temperatures such that the mean kinetic temperature (MKT) (see Pharmaceutical Stability (1150) for further discussion on MKT) is not greater than 25° C. If plastic materials are used for repackaging, the USP requires that these materials should afford better protection than PVC in other words, a Class A-type package is advocated. 

For products packaged in containers intended for dispensing by a pharmacy to multiple patients, or intended for repackaging or packaging in unit-of-use containers, samples may be taken from previously opened containers. More than one container should be sampled during the stability study. The sampling protocol should be submitted in the drug application. 

Stability studies have demonstrated that monoclonal antibodies are chemically stable in daily practice. Rituximab and trastuzumab infusion are stable for 6 mmiths when stored between 2 °C and 8 °C [39, 40]. Bevacizumab repackaged in syringes is stable for at least 3 months [41],... 

Paul M, Vieillard V, Roumi E, Cauvin A, Despiau MC, Laurent M et al (2012) Long-term stability of bevacizumab repackaged in 1 mL polypropylene syringes for intravitreal administration. Ann Pharm Fr 70(3) 139-154... 

New approaches to old problems are emphasized. For example, how do mathematical aerodynamicists turned petroleum engineers view the physical world Stare up the back end of a rocket lifting off Is that a fuselage with stabilizer fins, or is it a circular wellbore with radial fractures Pry open the maintenance box of your typical jet engine Are those cascades of airfoil blades, or are they distributions of stochastic shales Can the solutions that describe brittle failure be repackaged to model arrays of fractures, say, the natural fracture systems that spur horizontal drilling Very often, the problems (inaccurately) crunched by our fastest computers can be solved (accurately) using closed-form analytical solutions found in other scientific disciplines. 

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