Posts tagged with "content uniformity"



strip films with microparticles
24. April 2018
Although strip films are a promising platform for delivery of poorly water-soluble drug particles via slurry casting, the effect of critical materials attributes (CMAs), e.g., super-disintegrants on critical quality attributes (CQAs), including film disintegration time (DT), remains under-explored. A two-level factorial design is considered to examine the impact of the super-disintegrant (SDI) type (sodium starch glycolate and croscarmellose sodium), their amount, and film thickness. SDIs were...

Wet granulation Glatt
11. March 2018
Granulation is an integral step during pharmaceutical manufacturing of solid doses, which is usually followed by unit operations such as drying, milling, tableting and coating. Granulation is typically carried out to alleviate problems in powder handling, content non-uniformity, segregation and poor flow properties of powders. However, previous work carried out by Oka et. al. (Oka, Emady et al. 2015) points out that sometimes a wet granulation process might fail to give us a robust product ..

05. February 2018
Children requiring cortisol replacement therapy are often prescribed hydrocortisone doses of 2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split commonly in an attempt to deliver the correct dose. This study aimed to determine the dose variation obtained from quartered hydrocortisone tablets when different operators performed the splitting procedure and to ascertain whether better uniformity could be attained from mini-tablets as an alternative f

15. August 2017
Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contrib- uting factors.
21. June 2017
Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contributing factors. Excipient characteristics play key role in efficient blending process and final product quality. In this work the effect of excipient type and properties, blending technique and processing time on content uniformity was investigated.
19. June 2017
In this study, the origins of granule content non-uniformity in the high-shear wet granulation of a model two-component pharmaceutical blend were investigated. Using acetaminophen as the active pharmaceutical ingredient (API) and microcrystalline cellulose as the excipient, the distribution of the API across the granule size classes was measured for a range of conditions that differed in the duration of the initial dry mixing