PHARMA FOCUS: TABLETING & ENCAPSULATION
Kollitab DC 87 L – the
all-inone tableting solution Accelerating product development to shorten time to market, without compromising on the robustness of a tableting formulation. Maximising the reliability of large-scale tableting processes, while simplifying drug product production allowing for cost-optimised manufacturing at the same time – the targets of a formulator have never been more challenging. Thorsten Cech of BASF SE and Sithembiso Dlalisa of BASF South Africa explore modern co-processed excipients and computer-aided formulation development as effective tools to overcome these demanding tasks.
T
RADITIONALLY, AN ACTIVE pharmaceutical
projects, respectively. This is the area of conflict
dedicated API? No, surely not. That is not the claim.
ingredient (API) is formulated as an
where both an all-in-one tableting aid and a virtual
All-in-one excipients are optimised to simplify
immediate release tablet by combining
pharma assistant come in handy. Holistically, these
development, increase processing robustness and
various excipients. Each individual excipient
two tools simplify formulation development and free
reduce the overall cost of tablet manufacturing.
addresses a specific need in the overall formulation
up time and resources greatly re-quired.
Indeed, following the concept and utilising all its
concept. Typical requirements are:
overarching benefits provides various advantages
•
increasing the tablet volume with a filler
THE ALL-IN-ONE TABLETING AID
throughout the entire business, such as:
•
improving tablet strength with a binder
Co-processed excipients are well established
•
•
adjusting the disintegration features by
in the pharmaceutical community. Uniting the
employing a disintegrant
performances and synergies of cleverly combined
lowering the ejection force by selecting an
excipients and the benefits of a dedicated
effective lubricant.
manufacturing process, co-processed excipients
Further formulation components might also
provide performances that single components
•
be required such as wetting agents or glidants to
are uncapable to deliver. All-in-one excipients
improve the powder flow of the tableting blend.
evolutionarily developed from this concept (see
There is a huge selection of excipients available
purchasing benefits by reducing the number of vendors which reduces complexities
•
quality and regulatory benefits by minimising testing efforts and expenses, which reduces paperwork
•
warehousing benefits by minimising the number of excipients, freeing up expensive storage area
•
research and development benefits by
Table 1). By adding missing attributes, they are
simplifying formulation development and
to formulators. All these ingredients need to be
transformed to offer fully fetched formulation
shortening time-to-market, freeing up
evaluated, cleverly combined and their synergies
concepts, satisfying all the needs of an immediate
considered. The relevant ratios must also be
release target product profile.
examined to build up the required target product profile. Having such options is generally a desired feature and key for optimising formulations of demanding APIs. Though, in the field of low-tomid dose APIs, which do not require any special attention when being formulated as immediate release tablets, the situation is very different. Options ask for experience, knowledge, a huge stock of excipients, multiple trials, financial resources and substantial time investments. Time,
Formulation development is much more straight forward with Kollitab DC 87 L All-in-one components combine the
precious resources. •
production benefits by allowing for direct compression and streamlining of processes, hereby decreasing manufacturing complexity and risk of failure.
REDUCE COMPONENTS WITH KOLLITAB DC 87 L An evaluation of marketed drug products reveals that a huge variety of excipients are used in pharma manufacturing. To formulate four drug products, today’s formulation
being the most precious aspect of all, could be
functionalities required to formulate an immediate-
concepts easily require 15+ ingredients
spend in other projects.
release tablet, with the application ease of a
(four APIs and 11+ excipients). Utilising the
Consistently, formulators must balance
ready-to-use component and the robustness and
capabilities of an all-in-one component
their efforts. Time can either be invested in the
processing reliability of a customised formulation.
reduces the number of ingredients to five.
development of a standard tablet or put into challenging, yet commercially more interesting
18
QUARTER 1 2022 // P&C AFRICA
Is an all-in-one excipient specifically optimised to support customised formulation concepts of a
There are still four APIs, but just one excipient: Kollitab DC 87 L.
