SCIENTIFIC FORMULATION, ARTFUL DOSAGE DESIGN, SUCESSFUL TREATMENTS.

Enhance the bioavailability of your poorly water-soluble (BCS II and IV) compounds with softgel technology. Improve dose uniformity of your potent compounds and minimize patient-to-patient variability

  • Generate faster onset of action, reducing API dose, minimizing side effects, and improving your overall treatment performance
  • Reduce development time through a proven dosage form with a strong track record of commercial success
  • Get specialized handling and manufacturing for your hand difficult APIs
  • Reconsider your product life cycle management by generating a faster onset of action, reducing API dose, minimizing side effects, and improving your overall treatment performance with softgels.
  • Differentiate your brand with various color, shape, size and printing options and protect your softgels from counterfeiting and tampering
Image of a softgel capsule in orange colour

Softgel Manufacturing Services

  • Pre-formulation and Feasibility Studies: The initial phase of softgel development involves rigorous pre-formulation and feasibility studies. These are critical to assess the compatibility of the drug with softgel encapsulation and to ensure the robustness of the softgel product.
  • Solubility Screening of NCEs: New Chemical Entities (NCEs) undergo comprehensive solubility screening to determine their suitability for softgel formulation. This step is essential for identifying the appropriate softgel shell and fill materials.
  • Softgel Capsule Fill Formulation Development: Developing the fill formulation for softgel capsules is a complex process that requires careful consideration of the physical and chemical properties of the drug, ensuring its stability and bioavailability.
  • Small-scale Lab Encapsulation: Small-scale lab encapsulation processes provide early stability data for softgel formulations. This is crucial for final formulation selection and for predicting the shelf-life of the softgel product.
  • Shell Development: The development of the softgel shell is tailored to protect the active pharmaceutical ingredient (API) and to optimize the release profile. This involves selecting the right gelatin type, plasticizers, and other excipients.
  • Extensive Technical Support in Capsule Product Development: Softgel capsule product development is supported by extensive technical expertise. This ensures that each softgel is designed to meet the specific needs of the medication and the patients.
  • Reliable Supply from Clinical Phases to Commercial Manufacturing: Ensuring a reliable supply of softgels from clinical trial phases through to commercial manufacturing is paramount. This involves scaling up production while maintaining quality and consistency.
  • Contingency Planning and Quality Assurance: Contingency planning and rigorous quality assurance protocols are in place to guarantee the uninterrupted production of softgels. This includes risk management strategies for supply chain disruptions.
  • Strong IP Positions: Softgel formulations often come with strong intellectual property positions, including proprietary fill formulations that enhance bioavailability. This can provide a competitive edge in the pharmaceutical market.
  • Regulatory Compliance: Adherence to regulatory guidelines is essential in softgel manufacturing. This ensures that softgel products meet all safety, efficacy, and quality standards.
  • Patient-Centric Design: Softgel capsules are designed with the patient in mind, focusing on ease of administration and improving patient compliance.
  • Innovative Softgel Technologies: The field of softgel technology is ever-evolving, with new advancements aimed at improving the encapsulation process and the end product’s performance.
  • Environmental Sustainability: Modern softgel production increasingly incorporates sustainable practices, reducing environmental impact while maintaining product integrity.

Smaller Softgels

  • Compact and Easy-to-Swallow Softgels: Say goodbye to large pills and dosing uncertainties. Our softgels are designed to be compact and easy to swallow, ensuring optimal drug protection and release.
  • Advanced Encapsulation Technology: We utilize advanced droplet-based flow technology to replace outdated rotary die methods, providing a range of spherical softgel capsules from 1 to 7mm in size.
  • Adaptable Softgel Solutions: Our softgels are highly adaptable, capable of accommodating a variety of fill formulations. This flexibility allows us to meet the specific needs of diverse therapeutic compounds.
  • Top-Tier Shell Excipients: We use only the best shell excipients for our softgels, ensuring that each capsule is tailored to enhance the delivery and efficacy of the medication it contains.
  • Precision Dosing: Our softgel encapsulation process allows for precise dosing, eliminating the guesswork and variability often associated with other dosage forms.
  • Enhanced Bioavailability: The unique composition of our softgel formulations is designed to improve bioavailability, ensuring that patients receive the full therapeutic benefit of the medication.
  • Customizable Release Profiles: We can tailor the release profile of our softgels to match the therapeutic requirements, whether it’s immediate, delayed, or extended release.
  • Patient-Centric Design: Our softgel capsules are created with the patient’s experience in mind, focusing on ease of use, comfort, and adherence to treatment regimens.
  • Robust Stability: The integrity of our softgels is maintained through rigorous stability testing, ensuring that they remain effective throughout their shelf life.
  • Sustainable Manufacturing Practices: We are committed to environmental sustainability in our softgel manufacturing processes, reducing waste and conserving resources.

Abuse Deterrent Softgels


    • Physical Manipulation Studies: The company conducts physical manipulation studies, including crushing and grinding techniques, to ensure the softgel capsules’ integrity.
    • Hands-On Experience: Renejix has hands-on experience with multiple therapeutic classes, providing both extended and immediate release formulations in softgel form.
    • Extraction/Solubility Assessments: Renejix performs extraction and solubility assessments to evaluate the abuse potential of the softgel formulations.
    • Specialized Assessments: Specialized assessments of vaporization and syringeability/injectability are conducted to ensure the softgel capsules’ safety.
    • Market Comparison: Renejix’s softgel products are rigorously compared to marketed products to establish superiority in abuse deterrence.
    • Regulatory Conformance: The initial assessment phase is followed by protocol experiments, with all studies conforming to current regulatory guidelines for softgel capsules.
    • Documentation: Results are meticulously documented in final reports, which include photographs and video evidence of the softgel capsules’ abuse-deterrent features.

      BENEFITS

    • Accessible Technology: Renejix’s softgel technology is not only effective but also innovative, providing an abuse-resistant product that is accessible to a wide range of patients.
    • Multi-Level Abuse Prevention: Each softgel capsule is designed with multi-level abuse prevention technology, ensuring maximum protection against misuse.
    • Patient/Consumer Preferred Dose Form: The softgel dose form of Renejix’s product is preferred by patients and consumers for its ease of use and effectiveness.
    • Rapid Commercialization: With Renejix’s development and manufacturing expertise, the softgel product can be rapidly commercialized, reaching the market swiftly.
    • Proprietary Technology: Renejix’s proprietary softgel technology offers market protection, setting it apart from competitors.
    • Innovative Abuse Resistance: The innovative and effective abuse resistance of the softgel capsules meets the stringent scrutiny of the FDA and addresses public pressure hurdles.
    • Therapeutic Profiles: Renejix offers both immediate and extended release therapeutic profiles in softgel form, catering to diverse medical needs.
    • Patient Safety: Renejix prioritizes patient safety, with each softgel capsule undergoing rigorous testing to ensure it meets safety standards.
    • Continuous Innovation: Renejix is committed to continuous innovation, regularly updating the softgel technology to stay ahead of abuse techniques and regulatory requirements.
    • Collaborative Efforts: The company collaborates with regulatory bodies and healthcare providers to enhance the softgel capsules’ abuse-deterrent properties and patient accessibility.

Plant Based Softgels

  • Plant-Based Softgel Innovation: The plant-based softgel capsules feature a shell derived from potent plant polysaccharides, which allows for the encapsulation of fill formulations with elevated melting points, making these softgels suitable for a variety of health supplements and medications.
  • Enhanced Drug Delivery: These softgel capsules utilize semi-solid matrices that offer modified release options for poorly soluble and/or poorly permeable drug compounds, optimizing the delivery and efficacy of the medication.
  • Immediate Release Applications: The plant-based softgel technology expands the range of compatible excipients, facilitating the development of lipid-based capsule formulations and enabling teams to overcome drug delivery challenges with ease.
  • Broad Formulation Compatibility: The fusion of plant-based softgel technology with traditional softgel methods increases the excipient compatibility, allowing for the encapsulation of a wider range of lipid-based formulations.
  • Bioavailability Optimization: The softgel design significantly increases the bioavailability of a vast array of poorly water-soluble and poorly permeable compounds, enhancing the effectiveness of the encapsulated drugs.
  • Extended Release Proficiency: These softgels enable the modification or extended release of compounds, providing consistent therapeutic levels over an extended period.
  • Advanced Formulation Solutions: The plant-based softgel technology solves intricate development and formulation challenges that conventional softgel technology cannot address, offering advanced solutions for complex pharmaceutical needs.
  • Gelatin-Free Advantage: The softgel products are gelatin-free, catering to a broader consumer base, including those with dietary restrictions or preferences against animal-derived products.
  • Neutral Sensory Experience: These softgels eliminate any lingering shell odor and offer a remarkably neutral taste, improving the consumer experience and compliance with medication regimens.
  • High-Temperature Formulation Capability: The shell composition of the softgel is adept at handling high-temperature fill formulations (up to 70˚C), accommodating semi-solid and highly viscous fill formulations without compromising the integrity of the softgel.

Why Softgels

Improved Patient Experience: Seamless delivery helps patients struggling with swallowing, like pediatrics, geriatrics, and oncology cases. Embrace enhanced compliance and adherence, leaving behind administration struggles.

Effortless Dose Titration: Our sachets contain softgel capsules for easy, uniform administration. Each holds an equivalent therapeutic dose, simplifying adjustments from the same production batch.

Optimal Dose Uniformity: Ensure consistent dosing, minimizing variation across patients for potent compounds.

Exceptional Performance: Expect faster action, lower API doses, reduced side effects, and enhanced overall treatment performance.

Effortless Swallowing: Our comfortable softgels replace the stress of larger pills.

Seamless Dose Titration: Precision dosage adjustments are essential. We support indications requiring titration, ensuring your therapeutic needs are met seamlessly.

Superior Gelatin Capsules: Our gelatin shells match our normal size softgel’s high quality, ensuring reliability and effectiveness.

Customization: Stand out with our proprietary softgel technologies that provide unique shapes and sizes for customization, including twist-offs for accurate dosing and soft lozenges for improved patient compliance.

Enhanced patient adherence (particularly for elderly, dysphagic patients, young children) with effortlessly ingestible softgels

Maximized Therapeutic Window: Softgels can be designed to maximize the therapeutic window of a drug, which is the range between the minimum effective concentration and the minimum toxic concentration in the bloodstream. By fine-tuning the release mechanism, softgels help maintain drug levels within this optimal range, enhancing efficacy while reducing the risk of side effects.

Tailored Release Profiles for Precision Medicine: The versatility of softgel technology allows for the creation of tailored release profiles. Whether the therapeutic regimen calls for immediate, delayed, or extended release, softgels can be engineered to meet specific pharmacokinetic requirements, ensuring that the medication is released at the right time, at the right place, and in the right amount.

Enhanced Stability: Softgels provide a protective barrier that shields sensitive compounds from environmental factors such as light, oxygen, and moisture. This encapsulation ensures the stability and longevity of the medication, preserving its therapeutic properties until the moment of ingestion.

Thermal Resilience for Complex Formulations: The ability to encapsulate high-temperature fill formulations (up to 70˚C) opens new avenues for incorporating semi-solid and highly viscous compounds. This thermal resilience is crucial for drugs that require heat to maintain their efficacy or stability.

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FAQs

Here are some frequently asked questions about softgels.

What are softgel capsules?

Softgel capsules are a form of liquid-filled capsules made from a gelatin-based shell surrounding a liquid or semi-solid fill. Unlike hard-shell capsules, which are composed of two rigid halves, the softgel's shell is flexible and seamless, offering a unique dosage form for a wide range of active pharmaceutical ingredients (APIs). Softgels are valued for their ability to encapsulate high-potency drugs, improve bioavailability, and mask unpleasant tastes and odors.

How do softgels enhance drug bioavailability?

Softgels can enhance drug bioavailability by encapsulating the drug in a liquid form, which can be more readily absorbed by the body compared to solid dosage forms. The liquid fill can contain solubilized APIs, which are especially beneficial for poorly water-soluble drugs, facilitating faster dissolution and absorption in the gastrointestinal tract. Additionally, the formulation flexibility allows for the inclusion of solubilizers and emulsifiers to further improve the dissolution rate and absorption of the encapsulated drug.

What types of APIs are suitable for softgel encapsulation?

Softgel encapsulation is suitable for a wide range of APIs, including lipophilic (fat-soluble) compounds, poorly water-soluble drugs, liquids, and semi-solids. Softgels are particularly advantageous for APIs that require stabilization or are sensitive to oxygen or light, as the encapsulation offers a protective environment. This dosage form is versatile enough to accommodate various therapeutic categories, including vitamins and supplements, analgesics, antifungals, and cardiovascular drugs.

Can softgels be used for controlled-release formulations?

Yes, softgels can be formulated for controlled-release applications. By manipulating the gelatin shell composition and the fill formulation, it's possible to achieve various release profiles, including delayed-release, sustained-release, and targeted-release. These modifications allow for the precise control of drug release rates, enhancing therapeutic outcomes and patient compliance by reducing dosing frequency.

What are the advantages of softgels over other dosage forms?

Softgels offer several advantages over other dosage forms, including:

 

Improved Patient Compliance: Their smooth, flexible shape makes them easier to swallow compared to tablets or capsules.

Bioavailability Enhancement: The liquid fill can improve the absorption of poorly soluble drugs.

Taste Masking: The encapsulation masks the taste and odor of unpleasant APIs.

Protection of Sensitive Ingredients: The shell provides a barrier against light, oxygen, and moisture.

Dose Precision: Each softgel contains a precisely measured dose, reducing variability.

Aesthetic Appeal: Softgels are available in various shapes, sizes, and colors, enhancing patient acceptance.

What are the key considerations in softgel formulation development?

Key considerations in softgel formulation development include:

API Solubility: Ensuring the API is adequately soluble in the fill material to achieve the desired bioavailability.

Shell Composition: Selecting the appropriate gelatin type or alternative polymers to meet dietary or stability requirements.

Fill Excipients: Choosing excipients that enhance the API's stability and absorption without compromising the integrity of the shell.

Sealing Technology: Employing robust sealing techniques to prevent leakage and ensure product stability.

Compatibility: Ensuring compatibility between the API, excipients, and shell materials to maintain efficacy and extend shelf life.

How are softgel capsules manufactured?

Softgel capsules are manufactured using a rotary die process, where gelatin is heated and molded into two ribbons that form the capsule shell. The liquid or semi-solid fill is simultaneously injected between these gelatin ribbons, and the capsules are sealed and shaped by the dies. The capsules are then cooled, trimmed, and inspected for quality before packaging. This process requires precise control of temperature, humidity, and fill volume to ensure consistent product quality.

Can softgels accommodate combination therapies?

Yes, softgels are an excellent choice for combination therapies, as they can encapsulate multiple APIs within the same capsule. This capability allows for the combination of drugs with complementary therapeutic effects or the inclusion of both immediate-release and controlled-release components in a single dosage form. Combination therapy softgels can simplify treatment regimens, improving patient compliance and therapeutic outcomes.

What packaging options are available for softgels?

Softgels can be packaged in a variety of containers, including blister packs, bottles, and pouches, depending on the product's stability requirements and marketing considerations. Packaging is selected based on factors such as moisture sensitivity, light protection, and consumer convenience. Additionally, tamper-evident and child-resistant features can be incorporated to ensure product safety and compliance with regulatory standards.

How does Renejix ensure the quality and stability of softgel capsules?

Renejix ensures the quality and stability of softgel capsules through rigorous quality control and stability testing procedures. This includes:

Raw Material Testing: Verifying the purity and quality of gelatin, APIs, and excipients.

Process Control: Monitoring manufacturing conditions to maintain consistent shell thickness, fill volume, and seal integrity.

Finished Product Testing: Conducting physical, chemical, and microbiological tests to confirm capsule uniformity, API content, and dissolution characteristics.

Stability Studies: Assessing the product's shelf life under various environmental conditions to determine appropriate storage recommendations and expiration dating.