Continuous Manufacturing (CM) for Oral Solid Dosage Form

Wet granulation (WG) immediate release (IR)

In wet granulation processes, the fluid bed and high shear granulator, known as typical batch processes, are getting designed by manufacturers to be transferred into continuous manufacturing. Nowadays, the twin screw granulation, in which powders and liquids can be fed in a continuous way, are seen as a promising wet granulation technique to be implemented in a CM line. Besides the use of low viscosity hypromellose as binder: PHARMACOAT® or TYLOPUR®, the addition of multi-functional excipients, like L-HPC (low substituted hydroxypropylcellulose) can simplify the formulation.

Wet granulation (WG) sustained release (SR)

Wet granulation processes are generally used to improve flowability and homogeneity of powders. For the high shear granulation, the appropriate selection of organic solvent/ water ratio and the granulation time are key parameters to guaranty a good compactibility and steady dissolution profile of matrix tablets based on METOLOSE®/ TYLOPUR® SR (HPMC) (see technical information SR-003).

One advantage of using the twin screw granulation over other traditional wet granulation techniques is, besides being a more straight forward continuous process, the possibility of using only water. Indeed, shorter granulation time resulting in lower hydration of the HPMC allows to obtain similar granules properties and steady dissolution profiles compared to standard high shear granulation.

Roller compaction (RC) immediate release (IR)

Roller compaction is a dry granulation technique that is seen as a continuous process. The powder blend requires sufficient binding to form a stable ribbon and larger granules with less fine powders after the milling step. Powders are feed into the roller compactor thus the flow property and multifunctionality of powders similar to direct compression can be considered as key properties.

L-HPC NBD grades are low-substituted hydroxypropyl cellulose and increase the binding properties of your roller compaction formulation. At the same time L-HPC acts as disintegrant ensuring the quick disintegration of your roller compacted IR formulation. Best performance in roller compaction is given by the L-HPC NBD grades with optimized particle size distribution and compactibility.

Roller compaction (RC) sustained release (SR)

Roller compaction is a dry granulation technique that is seen as a continuous process. The powder blend requires sufficient binding to form a stable ribbon and larger granules with less fine powders after the milling step. Powders are feed into the roller compactor thus the flow property and multifunctionality of powders similar to direct compression can be considered as key properties.

Roller compactor can be selected for the preparation of hydrophilic matrix tablets for sustained release formulations. METOLOSE®/ TYLOPUR® SR (HPMC) manifest sufficient flowability to be feed into the roller compactor.

Direct compression (DC) immediate release (IR)

Direct compression is the easiest manufacturing process to be implemented as continuous process. Good flowing excipients are key to allow a homogenous feeding. The L-HPC NBD grades have optimized particle shape and particle size distribution designed to maximize the flow property.

The use of co-processed excipients like SmartEx® Plus with improved powder flow and functionality for direct compression additionally allows the reduction of the feeders in the CM line.

Direct compression (DC) sustained release (SR)

Hydrophilic matrix systems designed with water-soluble polymers, such as hypromellose (HMPC) allow more controllable and reproducible drug release by controlling the chemical and physical properties of the polymer. Typical grades used are METOLOSE® SR and TYLOPUR® SR. Both materials showing good flowability and steady batch to batch consistency are used in tablets formulations that can be transferred in a direct compression continuous manufacturing line.