Multiparticulates - for lifecycle management & line extensions only?

I follow pellets and multiparticulates for over 20 years and always wondered why the main application of pellet formulations were line extensions such as extended, sustained and controlled release drug products. The main reason seems to be that many drug products in development start with "enabling formulations" in very early stage preferably a powder filled capsule and later a standard immediate release tablet or capsule. There are certainly many reasons to do so which includes "keep the formulation simple" up to commercial production capability consideration not adding further risk factors to the project.

Pellets or multiparticulates mainly come into the game if standard solutions are not doing the job. Since some years due to the focus on more patient centric formulations and considerations for specific patient groups such as peadiatrics and geriatrics - I have felt sensation of a "revival" of multiparticulates. Talking about special patient groups and potential swallowing issues we should not forget that according to a study commissioned by HERMES PHARMA and executed by the SPIEGEL Institut Mannheim in 2015 more than 50% Americans and 60% Germans claim serious difficulties in swallowing tablets/capsules (swallowingtablets.com)

It is not only about swallowing tablets and capsules. Pellets might also make sense much earlier in the drug product development as a tool to avoid reformulation during the dose finding in the clinics. Instead of the needed work and time in reformulation, analytics and stability a simple adjustment of the amount of multiparticulates can safe time and money in a success critical phase. The initial workload might be higher at the very beginning but the development could go with the same formulation from bench to bedside - having a commercial formulation with adjustable dosing right from the start. In best case it can event be the platform for an extended / sustained / controlled release profile.

In the pharmaceutical industry, pellets are still described as complex formulations and with difficult manufacturing processes and this might be one of the reasons they are too much in the shadow looking at the solutions multiparticulates can offer including individual dosing (as nicely shown with minitablets already). There is a lot going on also in the field of handling and applying multiparticulates to get the full profit of this versatile drug delivery system. To increase the general knowledge on multiparticulates I like to share the webinar series by Dr. Norbert P?llinger from Glatt Pharmaceutical Services with several episodes on the different aspects mentioned included the advantages of pellets for the handling of high(er) potent drug. I hope you can profit from theses webinars.

Webinar Series on Multiparticulates

Multiparticulates 1 – A modern Oral Drug Products for our Society

Multiparticulates 2 - Multiparticulates from matrix core pellets – Glatt MicroPx and ProCell Technology

Multiparticulates 3 -?Multiparticulates from maxtrix core pellets – Glatt CPS

Multiparticulates 4a - Functional coating applications – The Basics

Multiparticulates 4b - Glatt Fluidbed Wurster Drug Layering and Coating - the Process

Multiparticulates 5 - Product and process development applying QbD (quality by design) and DoE (design of experiments) concepts to define DS (design space)

Multiparticulates 6 - DoE case studies in QbD development

Multiparticulates 7 - Next Generation ODTS with high dosed Multiparticulates

Multiparticulates 8 - Scale up considerations on the Wurster (bottomspray) fluidized bed process

Multiparticulates 9 - Pellets from fluid bed processes – a smart concept for high(er) potent drug processing

Multiparticulates 10 - Functional Tartaric Acid Pellets in Modern Formulation Challenges

If interested in the topic you will find further publications on and around pellets also on PharmaExcipients (Link to the "pellets" category). Articles are published on a daily basis.