TABLETING 81
Meeting specifications as well as expectations
A tablet must be designed to meet patient acceptance as well as meet the required tablet breaking force specification that impacts tablet friability and for many presentations determines the disintegration and dissolution profile of the tablet. Many tablets require bisect scores as well as identifying letters or numbers to be embossed on the surface of the tablets. Te engraving cuts must be designed keeping in mind the need for tablet coating as well as the potential for sticking and picking problems, which can impact the tablet compression process. Sticking and picking can also become a problem when the compression process is scaled up to meet full production for patient population supply. Modern high-speed rotary tablet presses can produce tablets in large numbers, but high-speed operation means shorter dwell times and the potential for problems with powder compaction. Te dwell time, which is defined as the period of time that a formulation is under maximum compression, is often the key to proper compaction of a powder.
Market demand pressures Often the marketplace demand for a product requires the production department to run their tablet presses at higher and higher output. If a formulation has not been designed to compensate for shorter dwell time by adding compression force to meet tablet breaking force and friability targets, then problems arise and production expectations cannot be met. In addition to tablet physical properties, there are often sticking and picking issues. Tese result because the compaction of the powder is insufficient and this has
Tablet design considerations such as embossing prepick and taper, engraving cut angles and radii need to be discussed to mitigate potential risks
resulted in a situation whereby some of the powder from the tablet is compelled to remain in the punch cup or in the letters of the embossing instead of staying with the tablet. Tis results in tablet defects and decreased production yields. Unfortunately, this problem may be identified after the product has been submitted to the regulatory agencies and changes to the formulation are challenging.
Defining product design space Part of the QbD process requires the definition of product design space. When a post submission problem is identified, it can sometimes be traced to insufficient development data that led to incorrect design space. To avoid these problems, it is in the best interest of the R&D staff to include their compression- tooling provider early on in the development process to alleviate future problems.
Considering the tablet design options Tablet design considerations such as embossing prepick and taper, engraving cut angles and radii and considerations for the cup depth and tool land need to be discussed to identify and mitigate potential risks in the initial and final designs.
If the formulation is
likely to provide sticking and picking problems, then the investment in proper identification of tool steel and coating is a worthy venture given the cost of remediating any sticking problems at a later date. Running a small performance batch using the production equipment at full rate will go a long way toward limiting the angst of having to solve a sticking problem post
submission when demand for the product is high.
For more information ✔ at
www.scientistlive.com/eurolab www.scientistlive.com
Charles N. Kettler Ph.D is director of Natoli Scientific.
www.natoli.com
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