Capsules are a significant part of the oral solid dosage (OSD) forms, widely used in pharmaceutical therapies. Despite their extensive use and established manufacturing lineage, capsules can pose considerable challenges. With the rise in complex molecules, it is crucial to offer diverse formulation and oral solid solutions for capsules.

Regardless of your project’s size or stage, we embrace your challenges and possess the expertise to deliver a broad range of capsule forms. This includes:

  • Hard and soft gelatin capsules
  • Delayed and extended-release capsules
  • Capsules for liquid, semi-solid, and solid fills
  • Capsules for dry powder inhalation (DPI)
  • Enteric-coated capsules
  • Capsules with beadlets or pellets for modified release
  • Capsules for reconstitution
  • Capsules with multiple-particulate fluid bead coating
An image of a capsule

Capsule Forms Offered

We offer a comprehensive range of services in capsule manufacturing. Our expertise spans across various types of capsules, each designed to cater to specific therapeutic needs and patient preferences. Here’s a detailed look at our capsule forms offered:

Hard Gelatin Capsules

We specialize in the production of hard gelatin capsules, which are ideal for a wide range of pharmaceutical applications. These two-piece capsules are perfect for encapsulating dry powder formulations and offer excellent stability and shelf-life.

Soft Gelatin Capsules

Our soft gelatin capsules are designed to encapsulate liquid or semi-solid fills. They are particularly useful for oil-based formulations and can significantly improve the bioavailability of poorly soluble drugs.

Modified Release Capsules

We offer modified release capsules that are designed to alter the drug release rate to achieve a therapeutic effect or to improve the drug’s delivery. These include sustained-release, controlled-release, and delayed-release capsules.

Enteric-Coated Capsules

Our enteric-coated capsules are designed to resist the acidic environment of the stomach and dissolve in the more alkaline environment of the intestine. This is particularly useful for drugs that are destroyed by stomach acid or that can irritate the stomach lining.

Custom Formulations

We understand that every drug is unique, and so are its formulation needs. Our team of expert pharmacists and scientists are capable of developing custom capsule formulations tailored to your specific requirements.

Quality Assurance and Control

Quality is at the heart of everything we do. We adhere to stringent quality control measures at every stage of the manufacturing process to ensure the safety, efficacy, and consistency of our capsules.

Regulatory Support

We provide comprehensive regulatory support to ensure that our capsules meet all necessary compliance requirements. Our team stays updated with the latest regulatory changes and can assist with documentation, submissions, and audits.

At Renejix Pharma Solutions, we are committed to delivering high-quality capsule manufacturing services that meet the needs of our clients and help improve patient outcomes. 

Capsules Manufacturing Process

Formulation Development: The active pharmaceutical ingredient (API) is carefully selected and prepared. The choice of excipients, preservatives, and stabilizers is critical to maintain the stability and efficacy of the medication.

Mixing and Homogenization: The API and excipients are mixed to ensure even distribution.

Capsule Filling: Automated filling machines are used to fill the capsules. These machines are a significant investment, which is why partnering with a CDMO increases the cost-efficiency of manufacturing for pharmaceutical companies. Soft gelatin capsules are filled at the same time they are produced, using a single rotary die encapsulation machine to form, fill, and seal the capsules.

Quality Control: Each batch of capsules is thoroughly tested to ensure it meets the required specifications for potency, purity, and dissolution.

Packaging: The capsules are then packaged in a manner that protects them from damage, contamination, and degradation.
Testing, Packaging & Shipping: Each batch of capsules is thoroughly tested to ensure it meets the required specifications for potency, purity, and dissolution. The capsules are then packaged in a manner that protects them from damage, contamination, and degradation.

Printing: The capsules can be printed with identifying marks.

Additional Benefits

Capsules offer several benefits:

  • Easy to Swallow: Capsules are often easier to swallow compared to other oral dosage forms, making them a preferred choice for patients who have difficulty swallowing.
  • Tasteless and Odorless: Capsules are tasteless and odorless, which can be beneficial for drugs that have an unpleasant taste or smell.
  • Rapid Dissolution: Capsules tend to break down more quickly than tablets, potentially offering faster relief from symptoms.
  • Tamper-Resistant: Capsules are often designed in a way that makes it difficult to split them in half or crush them, unlike tablets.
  • Versatility: Capsules can contain a variety of forms of medication, including powders, granules, pellets, or liquids.
  • Controlled Release: Certain types of capsules can be designed to release their contents over a longer period of time, providing sustained therapeutic effects.
  • Improved Bioavailability: Some capsules can improve the bioavailability of certain drugs, enhancing their absorption and effectiveness.
  • Patient Adherence: The convenience and ease of use of capsules can improve patient adherence to medication regimens

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.