Manufacturing Tablets With Pharmaceutical Dry Granulation

Dry granulation is a vital process that plays a crucial role in transforming dry powders into granules for tablet and capsule production. It's especially beneficial when dealing with moisture-sensitive or heat-sensitive materials. This process increases the material flowability facilitating faster and more consistent feeding into the downstream process. By achieving and maintaining these conditions, pharmaceutical manufacturers are better able to produce tablets and capsules with consistent weight, strength, and expectable distribution of the active pharmaceutical ingredient (API).

In this article, we'll delve into the intricacies of the dry granulation process, roll compactors, its features & benefits.

The Dry Granulation Process

• Material Preparation: The process begins with the blending of API and excipients to form a homogeneous powder mixture.
• Compaction: The homogeneous powder mixture is then fed into a compaction unit. Here, it's compressed between counter-rotating rollers forming compacted ribbons/ flakes of the material.
• Milling: The compacted ribbons are then passed through a milling system where the compacted ribbons are broken down into granules of the desired size.
• Final Blend: The granules are then blended with other excipients if needed to prepare the final tablet formulation.

Typically these processes require machines that are easy to clean and guarantee a high quality of the produced granules.

Pharmaceutical dry granulation with roll compactors

Roll compactors are used to granulate challenging and poor-flowing materials that are characterized as being moisture and/or heat-sensitive, having a low bulk density, an unfavorable particle size distribution, or poor compressibility. They help to produce tablets with uniform dosage, weight, robustness, desired dissolution rates, and ultimately, the best possible efficacy and bioavailability.

Fitzpatrick’s approach to roller compaction in Pharma

Fitzpatrick has been recognized as the most trusted name in roller compaction technology and dry granulation equipment for more than 70 years, our customers are supported by world-leading applications and development experts.

Fitzpatrick’s CCS Series of roll compactors produces uniform ribbons/flakes which translates into the formation of uniform granules. The optimized granulated material improves downstream powder flow characteristics and subsequently, maximizes tableting efficiencies. This is achieved via a unique dual-feed pre-compression feed system and precision real-time roll gap control.

The horizontal feed screw meters a consistent flow of powder to the process. The high-speed vertically mounted pre-compression screw provides deaeration and pre-compression of the product before the compaction stage, helping to achieve a more consistent ribbon density. Powder is optimally compressed without any gravitational bias before moving through the rollers.

In the compaction stage, powder is fed between two counter-rotating rolls and pressed, creating a dense, compact ribbon.

The hydraulic system produces a precise and constant force which ensures a uniform compact. To ensure the best possible ribbon is generated, gap control is achieved by automatically adjusting the “floating” roll via the CCS control panel’s feedback loop programming.

The inherent software of the CCS when combined with built-in security and administrative controls, provides an added layer of document/process control and accountability.

Fitzpatrick’s CCS Series offers a truly scalable equipment growth path. When production requirements increase, the CCS Series grows with you.

With every CCS machine, Fitzpatrick offers two unique milling setups.

One option is to use the integrated FitzMill™ with a knife rotor for “in-air” size reduction. This is typically adopted for harder compacts.

Another option can be equipped with a bar rotor for “crushing” reduction – used at low speeds for softer compacts and to reduce fines.

Fitzpatrick has developed the greatest selection of rotor & screen combinations and has made them available for the CCS range.

These distinctively configurable options can solve most powder conditioning requirements and achieve the tightest particle size distributions of any manufacturer. Virtually no manual adjustments are required, thereby eliminating the potential for operator error.

The CCS Series has been designed with the user in mind. Equipment is easy to maintain with fewer parts to remove during cleaning cycles, thereby maximizing uptime.

Whether you need to achieve a specific particle size and distribution for tablet compression, or mill heat-sensitive materials, Fitzpatrick can provide the best solution to fulfill your specific processing objectives.