Powder blending active ingredient

GM Irwin, GJ Dodson, LJ Ravin. Encapsulation of clomacron phosphate I. Effect of fiowability of powder blends, lot-to-lot variability, and concentration of active ingredient on weight variation of capsules filled on an automatic capsule filling machine. J Pharm Sci 59 547-550, 1970. 

The operator is instructed to combine the premix containing active ingredient B1 with active ingredient B2 and blend for 30 min. All 19 batches were handled as directed in the batch record. Oscillation of the slugs back to powder was accomplished in every case using the screen listed in the batch record. For final granulation, we found that each batch was blended for 30 min, as directed. There is no blend uniformity testing. 

The uniformity of the active ingredient in the powder blend prior to granulation can be assessed directly by taking samples of the powder blend from the granulator. This may be insightful during formulation development so that the impact of each of the unit operations on the uniformity of the finished granulations and the finished product can be clearly understood. 

Confectioner s sugar is not widely used in pharmaceutical formulations because the poor-flow characteristics prevent its use in direct-compression blends. However, confectioner s sugar is used when a smooth mouth feel or a rapidly dissolving sweetener is required, and when a milled/micronized active ingredient must be blended with a diluent of similar particle size for powders or wet granulations. 

Consider a blending study to determine the optimum blending time of a mixture of solid particulates or powders. An active pharmaceutical ingredient (API) was blended with three... 

Figure 4.12 Spectral images showing the differences in active ingredient distribution (Reproduced, with permission, from Lyon, R. C., Lester, D. S., Lewis, E. N, etal. (2002), Near infrared spectral imaging for quality assurance of pharmaceutical products analysis of tablets to assess powder blend homogeneity. AAPS Pharm Sci Tech, 3 (3), 1. Website www.malvern. com/LabEng/products/sdi/nir chemicaLimaging range.htm.).

Toth SJ, Madden JT, Taylor LS, Marsac P, Simpson GJ (2012) Selective imaging of active pharmaceutical ingredients in powdered blends with common excipients utilizing two-photon excited ultraviolet-fluorescence and ultraviolet-second order nonlinear optical imaging of chiral crystals. Anal Chem 84 5869-5875... 

The first was a 1986 paper by Ciurczak and Maldacker [29]. These investigators used NIR in the analysis of tablet formulation blends and examined three methods of data treatment spectral subtraction, spectral reconstruction, and discriminant analysis. Blends were prepared in which active ingredients (aspirin, butalbital, and caffeine) were either omitted from the formulation or varied over a concentration range of 90 to 110% of labeled strength. All samples were ground in a powder mill to ensure homogeneity, then scanned in a sample cup on a model 500C InfraAlyzer. 

The product concentrate for an aerosol contains the active ingredient and any solvent or filler necessary. Various propellant and valve systems, which must consider the solvency and viscosity of the concentrate-propellant blend, may be used to deliver the product from the aerosol container. Systems can be formulated as solutions, emulsions, dispersions, dry powders, and pastes. 

Li, W. and Worosila, G. D. Quantitation of active pharmaceutical ingredients and excipients in powder blends using designed multivariate calibration models by near-infrared spectroscopy. Int. J. Pharm. 295 213-219, 2005. 

---