Tablets, as a form of oral solid dosage (OSD), account for the majority of pharmaceutical therapies. Despite their wide-use and proven manufacturing pedigree, tablets can still present significant manufacturing challenges. Our diverse tablet forms cater to a wide array of therapeutic needs and patient preferences, ensuring the success of your project. We can navigate the complexities of tablet formulation and manufacturing.

Tablet Forms Offered

Mono and Bi-layer Tablets: These tablets allow for the combination of two Active Pharmaceutical Ingredients (APIs) or controlled release profiles. 

Fixed-Dose Combinations (FDCs): Tablets in the form of FDCs simplify medication regimens by combining multiple APIs into a single dosage. This enhances patient adherence and simplifies treatment protocols.

Micro and Mini Tablets: Specifically tailored for pediatric and geriatric patients, these smaller tablets for better swallowability and precise dosing making dosing more manageable and precise for these sensitive patient groups. 

Aqueous Film Coating: This process enhances the appearance and swallowability of tablets. It also provides a protective barrier for the API, ensuring drug stability and efficacy.

Customization Options: Our tablets are available in various shapes and sizes, with customization options such as film-coating, sugar-coating, or enteric-coating to meet specific therapeutic requirements.

Disintegration Control: We can control the disintegration time of the tablets to match the desired release profile. This ensures that the medication is released at the right time and at the right place in the body.

Taste Masking: For APIs with unpleasant tastes, we offer taste masking solutions. This improves patient compliance, especially in pediatric and geriatric populations.

High Potency Handling: We have the capability to handle high potency APIs. This ensures the safety and efficacy of the medication.

Regulatory Compliance: All our tablet manufacturing processes comply with regulatory standards. This ensures the quality and safety of our products.

HPAPI Tablets

HPAPIs in Tablets: HPAPIs (Highly Potent Active Pharmaceutical Ingredients) are effective at very low doses, typically at or below 150 µg/kg of body weight in humans. This makes them suitable for oral solid dosage forms like tablets, providing patients with ease of administration and accurate dosing. They are particularly significant in the development of cancer therapeutics, where approximately 60% of approved oncology treatments are based on HPAPIs.

Handling and Safety Measures: Our Contract Development and Manufacturing Organization (CDMO) employs robust containment strategies, such as isolators and contained transfer systems, to protect workers from exposure to HPAPIs and prevent environmental contamination. We use dedicated equipment for HPAPI handling to minimize the risk of cross-contamination, ensuring the purity of our tablets.

Formulation Challenges: Addressing the poor solubility and bioavailability of HPAPIs is a common formulation challenge for tablets. We utilize specialized techniques, such as particle size reduction and solid dispersion technology, to enhance drug absorption and effectiveness of tablets. We also ensure uniform dosing, especially when dealing with low concentrations of HPAPIs, through our precision manufacturing processes.

Manufacturing Considerations: The chemistry, manufacturing, and controls (CMC) of HPAPIs present unique challenges due to the stringent containment required. Our production processes for HPAPIs are characterized by high precision and control, which is essential due to the small quantities of the drug involved and the need for accurate dosing in the final tablet form. We implement stringent containment and control measures in the production of tablets to ensure safety and efficacy.

Additional Benefits

Flexible Manufacturing Solutions for Tablets: We offer flexible manufacturing solutions, adept at handling a spectrum of tablets, from routine to high-potency and complex forms. Our state-of-the-art facilities are specifically designed to accommodate a diverse range of tablets, including coated, matrix, bi-layered, and mini-tablets.

Packaging, Labeling, and Serialization of Tablets: We provide comprehensive end-to-end solutions for the packaging, labeling, and serialization of tablets. Our services cater to both clinical and commercial manufacturing, accommodating various packaging formats. Our advanced serialization services ensure compliance with global regulatory requirements.

Innovative Delivery Technologies for Tablets: Innovation is at the heart of our approach to tablets. We employ various delivery technologies, including sustained-, pulsed-, modified-, and delayed-release, to enhance the therapeutic effectiveness and patient convenience of your tablet product.

Quality Control and Analytical Development for Tablets: Our facilities feature cutting-edge quality control and microbiology labs dedicated to tablets. Alongside our preformulation and analytical development infrastructure, we ensure that every tablet meets stringent safety, efficacy, and quality standards.

Research and Development for Tablets: Our R&D pilot lab is pioneering the next generation of tablets. We work in close collaboration with our partners to develop tablet formulations that address specific therapeutic needs and market demands.

Temperature-Controlled Warehousing for Tablets: To preserve the integrity of your tablet products, we offer temperature-controlled warehousing solutions. This ensures that your tablets are stored under optimal conditions, maintaining their quality throughout the supply chain.

Services

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FAQs

Here are some frequently asked questions about Oral Solids

What are oral solid dosage forms, and why are they important?

Oral solid dosage forms include tablets, capsules, powders, and granules. They are the most popular method of drug delivery due to their convenience, stability, and ease of mass production. These forms allow for precise dosages, extended shelf life, and improved patient compliance, making them a staple in both over-the-counter and prescription medication markets.

What services do you offer related to oral solid dosage forms?

We offer comprehensive services for oral solid dosage forms, including formulation development, process optimization, scale-up, and manufacturing. Our capabilities extend to immediate and controlled-release formulations, coating, encapsulation, and the development of chewable, dispersible, and effervescent tablets. We also provide packaging and analytical testing services to ensure product quality and compliance.



How does your CDMO ensure the quality and compliance of oral solid dosage products?

 Quality and compliance are paramount in our operations. We adhere to Good Manufacturing Practices (GMP) and are regularly inspected by regulatory authorities like the FDA and EMA. Our quality control processes include rigorous testing of raw materials, in-process materials, and finished products. We also implement robust quality assurance protocols, including validation and stability studies, to ensure our products meet all regulatory standards.



Can you handle controlled substances?

 Yes, we have specialized facilities and containment systems designed to safely handle controlled substances. Our team is experienced in managing the unique challenges associated with these substances, including stringent regulatory requirements and the need for specialized equipment and safety protocols.

What is your capacity for oral solid dosage form production?

Our production capacity is flexible and scalable to meet the needs of our clients, ranging from small-scale batch production for clinical trials to large-scale manufacturing for commercial supply. Our facilities are equipped with state-of-the-art machinery for granulation, compression, and coating, allowing us to efficiently produce a wide range of batch sizes with high precision and consistency.

How do you support the development of generic and novel oral solid dosage forms?

For generic products, we focus on bioequivalence studies, cost-effective formulation, and process optimization to ensure competitive market entry. For novel oral solid dosage forms, we collaborate closely with our clients to develop innovative formulations that enhance bioavailability, improve patient compliance, and extend product lifecycle, leveraging our expertise in drug delivery technologies and formulation science.

What is your approach to formulation development and optimization for oral solids?

Our formulation development and optimization process is data-driven and collaborative. We utilize Quality by Design (QbD) principles, incorporating thorough understanding of the drug substance, target product profile, and manufacturing processes. We employ advanced modeling and simulation tools, along with high-throughput screening methods, to rapidly identify and optimize formulations that meet the desired product attributes.

How do you manage project timelines and ensure timely delivery of oral solid dosage forms?

 Project management is a core competency of our operations. We assign dedicated project managers to each client, who oversee all aspects of the project from inception to delivery. Our project managers work closely with clients to establish clear timelines, milestones, and communication plans. We utilize agile manufacturing practices and real-time monitoring to ensure projects remain on track and adjustments are made proactively to meet delivery commitments.

Can you provide examples of successful partnerships in developing and manufacturing oral solid dosage forms?

While confidentiality agreements restrict the details we can share, we have successfully partnered with numerous pharmaceutical companies to bring both generic and innovative oral solid dosage products to market. Our collaborations often involve overcoming complex formulation challenges, scaling up novel production processes, and navigating regulatory approvals efficiently.

How can a pharmaceutical company start a project with your CDMO for oral solid dosage form development or manufacturing?

 Starting a project with us is straightforward. Interested pharmaceutical companies can contact us through our website, email, or phone to schedule an initial consultation. During this consultation, we discuss the project scope, objectives, and timelines. Following this, we provide a proposal outlining our services, timelines, and cost estimates. Upon agreement, we initiate the project with a kick-off meeting to align on project details and establish communication protocols.