Formulation and Development of Oral Dosage Forms

Upperton is a leading contract development and manufacturing organisation (CDMO) with extensive expertise in oral solid dosage (OSD) development and manufacturing, providing flexible, high-quality tablet solutions from early-stage development through to commercial manufacture.

Tablet Development Capsule Development

Oral Dosage Forms

Tablet Formulation: A General Overview

Tablets continue to be one of the most popular pharmaceutical dosage forms, as with the right tablet formulation you can achieve: ease of handling and administration for patients, stability convenient packing options, and well-established cost-effective manufacturing processes which produce consistent quality products. 

However, there are also disadvantages which can include: poor bioavailability, instability within the gastrointestinal (GI) tract and the potential of causing irritant effects or harming the GI mucosa. Many of these can be mitigated against through successful tablet formulation development. 

Our Oral Process Capabilities

Our oral process capabilities support the development and manufacture of a broad range of drug products, from early-stage development through to larger-scale batch manufacture.

Blending

Dry Granulation

Milling

Coating

Tablets

Immediate-release, modified-release and minitablets

Capsules

Drug Product Expertise

Small molecules, biologics and NCEs

Batch Sizes

From grams through to 250 kg batch sizes

Oral Dosage Forms

Discover Upperton's Oral Dosage Form Capabilities

Formulation strategies for tablets involve a meticulous process that considers various factors to ensure the efficacy and safety of the medication. Pharmaceutical scientists utilise a combination of active pharmaceutical ingredients, excipients, and manufacturing techniques to develop tablet formulations that meet specific requirements. These strategies may include selecting the appropriate binder, disintegrant, lubricant, and filler to achieve the desired characteristics such as hardness, disintegration time, and stability. Furthermore, optimising formulation parameters like particle size distribution, compression force, and coating thickness plays a crucial role in enhancing drug release profiles and bioavailability. 

Tablets consist of one or more API and a number of excipients that impart various functional attributes onto the tablet formulation and its performance both in during processing and following administration to the patient. Tablet formulation plays a crucial role in the effectiveness and safety of pharmaceutical products. By carefully selecting the right combination of active pharmaceutical ingredients (API) and excipients, pharmaceutical companies can ensure that tablets are easy to handle, administer, and store. The formulation process also involves addressing challenges like bioavailability and gastrointestinal stability to enhance patient outcomes. In addition to the technical aspects, tablet formulation development requires an understanding of manufacturing processes that ensure consistent quality while keeping production costs in check. This comprehensive approach is essential for creating tablets that meet regulatory standards and provide optimal therapeutic benefits to patients. 

Explore our CDMO services

Discover Upperton's Oral Dosage Form Capabilities

Oral administration remains the most widely used route for the successful delivery of active pharmaceuticals to patients. Discover how a CDMO partnership can streamline your drug development journey. 

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Oral Dosage Forms

Tablet Press

Once the powder blend is in a suitable state for compression it is transferred to the tablet machine. The powder blend with the uniformly distributed API and suitable flow properties feeds into a die cavity and compressed to controlled weight and hardness between an upper and lower punch. The design of the punches can be used to make tablets of various shapes and sizes and to include attributes such as a break-line or to add an identification mark or dose strength onto the tablets during compression. 

Tablet presses come in many sizes and with a range of capabilities, the speed of rotation and the number of stations dictating the potential output delivered from a few hundred per hour to over a million per hour. Careful control of the processing parameters such as compaction pressure and speed are required to ensure all tablets are produced to the same specifications. 

Once manufactured, the tablet core needs to be subjected to further processing operations such de-dusting to remove any loss uncompacted powder on the tablet surface collected from the tablet press. The tablet core also needs to be metal checked to ensure that no metal fragments have been inadvertently picked from a damaged tablet machine or tablet punch. 

In most cases tablets are then film coated. Coating can be performed by a number of techniques such as fluid bed coating or pan coating in equipment such as the O Hara Labcoat MX as used at Upperton. In some instances, the coating is non-functional and is purely for handling, administration or aesthetic reasons. In other instances the coating may be required to control the release profile of the tablet such as enteric coating which ensures that tablet will not disintegrate in the stomach pH or for taste masking to ensure the patient is not put off taking the medicine by an unpleasant taste. 

Overall, the tablet process offers a vast array of options for the formulation scientist to ensure that the API is delivered to the patient in a form that is easy to administer and is of a consistent quality with the desired release profile. 

OSD Tablets

Granulation Techniques

We offer both wet and dry granulation to improve the processing and performance of your tablet.

01

Wet Granulation

in order to improve the processability of the powder blend and / or to modified its powder flow characteristics, its mechanical properties, drug homogeneity and its release performance additional excipients (e.g. binders and disintegrants) may be required. These are added to the API blend with a granulation fluid whilst applying a range of mixing techniques (e.g. low shear, high shear, fluid bed). The wet mas is then typically passed through a screen, dried, milled and blended before it is suitable for compressing on a tablet machine. The increased number of unit operations make this process more complex with many more critical process parameters to control and monitor while the requirements to wet the materials and then dry the materials often presenting stability challenges.

02

Dry Granulation

As with wet granulation this process is applied to improve the processing and performance characteristics of the powder blend to be compressed. In dry granulation additional excipient (e.g. binders and disintegrants) are again added to the blend and then using a roller compactor, high pressure rollers force the mixed powder blend together and result in adhesion of the particles into ribbons. These ribbons are then broken down into granules using a granulation screen / mill. Following a final blend, the material is then suitable for tablet compression. Again, there are a number of critical process parameters that must be controlled but the elimination of a wet granulation fluid and the requirement for drying make this more efficient process and more suitable for API that have stability issues associated with wet granulation.

partnership

Why Partner with Upperton

We provide fully integrated services across every stage of drug product development:

Microscope and analysis equipment at the Upperton facility

One Site

Integrated, end-to-end capabilities delivered under one roof.

Upperton scientist examining a formulation flask

One Team

The same team from your early-stage development through to preparation for commercial launch.

Test tubes used in complex molecule formulation development

Complex Molecule Expertise:

Proven track record in solving formulation and delivery challenges.

Upperton senior leadership overseeing laboratory work

Executive Leadership on Every Project:

Direct access to experienced senior leadership for strategic oversight and decision-making.

Tablet Development & Manufacturing FAQs

The stages of tablet formulation typically include pre-formulation studies, selection of excipients and active pharmaceutical ingredients (APIs), granulation, compression into tablets, quality control checks such as weight sorting and metal checking, and finally coating if necessary for functionality or aesthetics. Each stage plays a crucial role in ensuring the final product meets specifications and delivers the API effectively to the patient. 

Different types of tablets can vary significantly in their formulation based on factors such as the desired release profile, intended administration route, and patient preferences. For example, immediate-release tablets, such as compressed tablets, are formulated to release the drug quickly once ingested, providing rapid therapeutic effects. On the other hand, extended-release tablets, like compression-coated tablets, are designed to deliver the drug over an extended period of time, allowing for less frequent dosing. Additionally, chewable tablets are formulated to be easily chewed and swallowed without water, making them convenient for patients with swallowing difficulties or children. Effervescent tablets contain ingredients that react with water to release carbon dioxide gas, resulting in a fizzy solution that can be more palatable for some individuals. Disintegrating tablets, on the other hand, rapidly break down in the mouth without the need for additional liquid or chewing, making them a suitable option for patients with difficulty swallowing or those who prefer not to chew their medication. Each type of tablet formulation is tailored to meet specific patient needs and preferences while ensuring the effective delivery of the active pharmaceutical ingredient through disintegration. 

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