Issue link: https://www.e-digitaleditions.com/i/1022930
20 September 2018 Tablets & Capsules fate, and polyethylene glycol (PEG). Moreover, one respondent reported that anything that helps to improve compaction strength is also useful to prevent sticking. Process and equipment. Depending on the phase of development, changes to the drug substance properties or formulation may not be possible based on regulatory considerations. In this situation, the few remaining options include adjusting the process parameters, equip- ment design, or environmental processing conditions. The manufacturing process being used will determine how many options are available to help reduce sticking. For example, a direct-compression process will have fewer processing levers to pull than a wet-granulation process. Unsurprisingly, respondents ranked direct com- pression as the platform that is most prone to sticking, followed by dry granulation, hot-melt extrusion, flu- id-bed granulation, twin-screw granulation, and high- shear wet granulation, respectively. If the manufacturing platform has already been locked, lubricant and grade for the formulation may be the pri- mary formulation mechanisms to eliminate sticking. Respondents ranked magnesium stearate as the most effective lubricant, followed by sodium stearyl fumarate, glyceryl behenate, stearic acid, and leucine, respectively. Respondents ranked removal of a formulation compo- nent as the third most effective strategy for eliminating sticking, and it is worth noting that five responses men- tioned the removal of mannitol. This is consistent with published information, which states that mannitol often requires higher lubricant concentrations than other excipients [5]. Interestingly, respondents noted both removal and addition of silicon dioxide to help mitigate sticking, confirming that glidants and lubricants can interact and alter each other's functionality [6]. Other formulation components respondents recog- nized as having an ability to prevent sticking were smaller particle-size grades of dry binders (such as smaller grades of microcrystalline cellulose), sodium lauryl sul- Table 3 Process and equipment changes that help eliminate sticking Rank Process or equipment change 1 Compression tooling (use of coated tools, embossing design or removal, cup design, shape, etc.) 2 Lubricant blend parameters (lubricant blend time and/or speed) 3 Compression parameters (feed frame paddle speed, pre-compression force, main compression force, tableting speed, etc.) 4 Granulation parameters (roll force, roll speed, ribbon solid fraction, moisture addition, wet massing time, etc.) 5 Milling parameters (screen size, mill speed, impeller type) 6 Non-lubricant blending parameters (order of material addition, pre-lubricant blending time and/ or speed, etc.) The Solids Flow Experts If you have a Particle, We can Characterize it Dedicated to providing cost effec�ve engineered solu�ons based on measure- ment of key material flow proper�es. We can combine material flow property tes�ng with nearly 40 years consul�ng experience to solve any flow and han- dling problems facing today's producers of fine powders and granules. Cu s t o m D es i g n s Call us: +1-352-379-8879 Visit us: www.ma�lowsol.com