Oral solid dosage (OSD) forms account for the majority of pharmaceutical therapies. Despite their wide-use and proven manufacturing pedigree, OSDs can still present significant challenges. With an increase in complex molecules, it is critical to provide diverse formulation and oral solid solutions.

If you’re searching for a CDMO partner that is completely focused on the success of your OSD project, look no further than Renejix. Whatever your project size or stage, we welcome your challenges and have the expertise to deliver a wide range of oral solid dosage forms. This include:

  • Tablets (mono and bi-layer) – immediate and modified release delivery systems
  • Fixed-dose combinations (FDCs)
  • Micro and Mini tablets
  • Aqueous film coated tablets
  • Capsules
  • Beads, including multi-particulate fluid bead coating
  • Granules for reconstitution
  • Powders including powder-in-bottle (PiB) dosage forms
  • Stick packs
Image of a Tablet

Oral Solid Forms Offered

  • Oral Solids and Bi-layer Tablets: Our oral solids portfolio includes bi-layer tablets, which allow for the combination of two Active Pharmaceutical Ingredients (APIs) or distinct release profiles, offering a versatile solution for combination therapies.
  • Oral Solids and Fixed-Dose Combinations (FDCs): The oral solids form of FDCs simplifies medication regimens by combining multiple APIs into a single dosage, thereby enhancing patient adherence and simplifying treatment protocols.
  • Micro and Mini Tablets: Tailored for pediatric and geriatric patients, our oral solids range features micro and mini tablets, making dosing more manageable and precise for these sensitive patient groups.
  • Aqueous Film Coating: Our oral solids’ aqueous film coating process not only enhances the appearance and swallowability of tablets but also provides a protective barrier for the API, ensuring drug stability and efficacy.
  • Multi-particulate Bead Coating: Oral solids benefit from our multi-particulate bead coating, which ensures a uniform coating for multiparticulate systems, guaranteeing consistent release profiles and dose uniformity.
  • Granules and Powders: Our oral solids offerings include granules and powders that are suitable for reconstitution or direct consumption, providing flexibility in administration and catering to various release profile needs.
  • Stick Packs: Emphasizing convenience and portability, our oral solids stick packs are an excellent choice for medication on the go, ensuring ease of use and precise dosing.
  • Tablets: Our oral solids 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.
  • Capsules: The oral solids form of capsules, whether hard or soft gelatin, can be filled with powders, granules, or microgranules, offering a versatile and widely accepted dosage form.

HPAPI Oral Solids

Understanding HPAPIs:

HPAPIs are defined as pharmacologically active ingredients that exhibit biological activity at very low doses, typically at or below 150 µg/kg of body weight in humans. These potent compounds are effective at very low doses, which makes them suitable for oral solid dosage forms like tablets and capsules, 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 Complexities of Highly Potent Oral Solids: Our Contract Development and Manufacturing Organization (CDMO) is fully equipped to navigate the complexities associated with the handling, development, and  production of highly potent oral solids, ensuring that every product meets the rigorous safety and efficacy standards through meticulous process control and quality assurance.

Handling and safety measures are critical to ensure the well-being of workers and the environment, as well as the quality and efficacy of the pharmaceutical products. Here’s a detailed look at these measures:

Handling and Safety Measures:

  • Containment: We employ robust containment strategies, such as isolators and contained transfer systems, to protect workers from exposure to HPAPIs and prevent environmental contamination. These systems are critical in maintaining a controlled environment for the safe handling of potent compounds.
  • Environmental Monitoring: Our facilities are equipped with state-of-the-art environmental monitoring systems that continuously check for any potential exposure to HPAPIs. This ensures a safe manufacturing environment and helps in immediate response to any containment breaches.
  • Equipment: We use dedicated equipment for HPAPI handling to minimize the risk of cross-contamination. This ensures the purity of our oral solids and protects the integrity of our products.
  • Training: Our personnel are rigorously trained in HPAPI handling and safety procedures. They are well-versed in the proper use of containment systems and are committed to maintaining the highest safety standards.

Formulation Challenges:

  • Solubility and Bioavailability: Addressing the poor solubility and bioavailability of HPAPIs is a common formulation challenge. We utilize specialized techniques, such as particle size reduction and solid dispersion technology, to enhance drug absorption and effectiveness of oral solids.
  • Innovative Coating Techniques for Oral Solids: We utilize innovative coating techniques in our oral solids manufacturing, which enhance the stability and release profiles of HPAPIs, providing tailored therapeutic effects.
  • Uniform Dosing: Ensuring uniform dosing, especially when dealing with low concentrations of HPAPIs, is critical. Our precision manufacturing processes are designed to deliver consistent and accurate dosing for oral solids.
  • Toxicity Data: The development of HPAPIs often faces the challenge of limited toxicity data. We conduct extensive research and risk assessments to ensure safe handling and formulation practices.
  • Containment in Formulation: The formulation process for HPAPIs is conducted under strict containment to protect our formulators and manufacturing personnel from exposure, ensuring their safety and the safety of the end product.

Manufacturing Considerations:

  • CMC Challenges: The chemistry, manufacturing, and controls (CMC) of HPAPIs present unique challenges due to the stringent containment required. We have developed specialized CMC protocols to address these challenges effectively.
  • Precision and Control: Our production processes for HPAPIs are characterized by high precision and control. This is essential due to the small quantities of the drug involved and the need for accurate dosing in the final oral solid dosage form.
  • Stringent Containment for Oral Solids: We implement stringent containment and control measures in the production of oral solids, which are crucial for maintaining the integrity and quality of high potency active pharmaceutical ingredients (HPAPIs), regardless of the batch size.

Additional Benefits

  • Flexible Manufacturing Solutions:
    • Our CDMO offers flexible manufacturing solutions, adept at handling a spectrum of oral solids, from routine to high-potency and complex oral solid dose (OSD) forms. We ensure the highest product quality across various scales.
    • Our state-of-the-art facilities are specifically designed to accommodate a diverse range of oral solids, including coated, matrix, bi-layered, and mini-tablets, as well as capsules with combination fillings.
  • Packaging, Labeling, and Serialization:
    • We provide comprehensive end-to-end solutions for the packaging, labeling, and serialization of oral solids. Our services cater to both clinical and commercial OSD manufacturing, accommodating various packaging formats.
    • Our advanced serialization services for oral solids ensure compliance with global regulatory requirements, offering our partners complete peace of mind.
  • Innovative Delivery Technologies:
    • Innovation is at the heart of our approach to oral solids. We employ various delivery technologies, including sustained-, pulsed-, modified-, and delayed-release, to enhance the therapeutic effectiveness and patient convenience of your drug product.
  • Quality Control and Analytical Development for Oral Solids:
    • Our facilities feature cutting-edge quality control and microbiology labs dedicated to oral solids. Alongside our preformulation and analytical development infrastructure, we ensure that every OSD meets stringent safety, efficacy, and quality standards.
  • Research and Development:
    • Our R&D pilot lab is pioneering the next generation of oral solids. We work in close collaboration with our partners to develop oral solid formulations that address specific therapeutic needs and market demands.
  • Temperature-Controlled Warehousing:
    • To preserve the integrity of your oral solid drug products, we offer temperature-controlled warehousing solutions. This ensures that your OSDs are stored under optimal conditions, maintaining their quality throughout the supply chain.
  • Oral Solids and Bi-layer Tablets: Our oral solids portfolio includes bi-layer tablets, which allow for the combination of two Active Pharmaceutical Ingredients (APIs) or distinct release profiles, offering a versatile solution for combination therapies.
  • Oral Solids and Fixed-Dose Combinations (FDCs): The oral solids form of FDCs simplifies medication regimens by combining multiple APIs into a single dosage, thereby enhancing patient adherence and simplifying treatment protocols.
  • Micro and Mini Tablets: Tailored for pediatric and geriatric patients, our oral solids range features micro and mini tablets, making dosing more manageable and precise for these sensitive patient groups.
  • Aqueous Film Coating: Our oral solids’ aqueous film coating process not only enhances the appearance and swallowability of tablets but also provides a protective barrier for the API, ensuring drug stability and efficacy.
  • Multi-particulate Bead Coating: Oral solids benefit from our multi-particulate bead coating, which ensures a uniform coating for multiparticulate systems, guaranteeing consistent release profiles and dose uniformity.
  • Granules and Powders: Our oral solids offerings include granules and powders that are suitable for reconstitution or direct consumption, providing flexibility in administration and catering to various release profile needs.
  • Stick Packs: Emphasizing convenience and portability, our oral solids stick packs are an excellent choice for medication on the go, ensuring ease of use and precise dosing.
  • Tablets: Our oral solids 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.
  • Capsules: The oral solids form of capsules, whether hard or soft gelatin, can be filled with powders, granules, or microgranules, offering a versatile and widely accepted dosage form.

Understanding HPAPIs:

HPAPIs are defined as pharmacologically active ingredients that exhibit biological activity at very low doses, typically at or below 150 µg/kg of body weight in humans. These potent compounds are effective at very low doses, which makes them suitable for oral solid dosage forms like tablets and capsules, 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 Complexities of Highly Potent Oral Solids: Our Contract Development and Manufacturing Organization (CDMO) is fully equipped to navigate the complexities associated with the handling, development, and  production of highly potent oral solids, ensuring that every product meets the rigorous safety and efficacy standards through meticulous process control and quality assurance.

Handling and safety measures are critical to ensure the well-being of workers and the environment, as well as the quality and efficacy of the pharmaceutical products. Here’s a detailed look at these measures:

Handling and Safety Measures:

  • Containment: We employ robust containment strategies, such as isolators and contained transfer systems, to protect workers from exposure to HPAPIs and prevent environmental contamination. These systems are critical in maintaining a controlled environment for the safe handling of potent compounds.
  • Environmental Monitoring: Our facilities are equipped with state-of-the-art environmental monitoring systems that continuously check for any potential exposure to HPAPIs. This ensures a safe manufacturing environment and helps in immediate response to any containment breaches.
  • Equipment: We use dedicated equipment for HPAPI handling to minimize the risk of cross-contamination. This ensures the purity of our oral solids and protects the integrity of our products.
  • Training: Our personnel are rigorously trained in HPAPI handling and safety procedures. They are well-versed in the proper use of containment systems and are committed to maintaining the highest safety standards.

Formulation Challenges:

  • Solubility and Bioavailability: Addressing the poor solubility and bioavailability of HPAPIs is a common formulation challenge. We utilize specialized techniques, such as particle size reduction and solid dispersion technology, to enhance drug absorption and effectiveness of oral solids.
  • Innovative Coating Techniques for Oral Solids: We utilize innovative coating techniques in our oral solids manufacturing, which enhance the stability and release profiles of HPAPIs, providing tailored therapeutic effects.
  • Uniform Dosing: Ensuring uniform dosing, especially when dealing with low concentrations of HPAPIs, is critical. Our precision manufacturing processes are designed to deliver consistent and accurate dosing for oral solids.
  • Toxicity Data: The development of HPAPIs often faces the challenge of limited toxicity data. We conduct extensive research and risk assessments to ensure safe handling and formulation practices.
  • Containment in Formulation: The formulation process for HPAPIs is conducted under strict containment to protect our formulators and manufacturing personnel from exposure, ensuring their safety and the safety of the end product.

Manufacturing Considerations:

  • CMC Challenges: The chemistry, manufacturing, and controls (CMC) of HPAPIs present unique challenges due to the stringent containment required. We have developed specialized CMC protocols to address these challenges effectively.
  • Precision and Control: Our production processes for HPAPIs are characterized by high precision and control. This is essential due to the small quantities of the drug involved and the need for accurate dosing in the final oral solid dosage form.
  • Stringent Containment for Oral Solids: We implement stringent containment and control measures in the production of oral solids, which are crucial for maintaining the integrity and quality of high potency active pharmaceutical ingredients (HPAPIs), regardless of the batch size.
  • Flexible Manufacturing Solutions:
    • Our CDMO offers flexible manufacturing solutions, adept at handling a spectrum of oral solids, from routine to high-potency and complex oral solid dose (OSD) forms. We ensure the highest product quality across various scales.
    • Our state-of-the-art facilities are specifically designed to accommodate a diverse range of oral solids, including coated, matrix, bi-layered, and mini-tablets, as well as capsules with combination fillings.
  • Packaging, Labeling, and Serialization:
    • We provide comprehensive end-to-end solutions for the packaging, labeling, and serialization of oral solids. Our services cater to both clinical and commercial OSD manufacturing, accommodating various packaging formats.
    • Our advanced serialization services for oral solids ensure compliance with global regulatory requirements, offering our partners complete peace of mind.
  • Innovative Delivery Technologies:
    • Innovation is at the heart of our approach to oral solids. We employ various delivery technologies, including sustained-, pulsed-, modified-, and delayed-release, to enhance the therapeutic effectiveness and patient convenience of your drug product.
  • Quality Control and Analytical Development for Oral Solids:
    • Our facilities feature cutting-edge quality control and microbiology labs dedicated to oral solids. Alongside our preformulation and analytical development infrastructure, we ensure that every OSD meets stringent safety, efficacy, and quality standards.
  • Research and Development:
    • Our R&D pilot lab is pioneering the next generation of oral solids. We work in close collaboration with our partners to develop oral solid formulations that address specific therapeutic needs and market demands.
  • Temperature-Controlled Warehousing:
    • To preserve the integrity of your oral solid drug products, we offer temperature-controlled warehousing solutions. This ensures that your OSDs are stored under optimal conditions, maintaining their quality throughout the supply chain.

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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.