Patented MDI Technology

Respitab is an innovative tablet-based technology platform designed for use in pressurized metered dose inhalers (pMDIs), offering a novel approach to inhalation product formulation and manufacturing. Unlike conventional pMDI suspension processes, which require complex mixing and homogenization of drug particles in propellant, Respitab enables the drug and excipients to be compressed into a solid tablet (the “Respitab”) that is then placed directly into the inhaler canister.

Key Features and Advantages

  • Simplified Manufacturing
    The Respitab process eliminates the need for high-shear mixing, homogenization, and continuous agitation during filling. Tablets are manufactured using standard tablet presses and are simply dropped into canisters before propellant filling, streamlining production and reducing equipment requirements.
  • Enhanced Batch Uniformity
    Each Respitab tablet contains a pre-measured dose of active pharmaceutical ingredient (API) and excipients, ensuring through batch uniformity and minimizing batch-to-batch variability.
  • Reduced API Loss and Waste
    By avoiding bulk suspension handling and cleaning steps, Respitab minimizes API loss and cross-contamination risk, making it especially advantageous for costly or potent drugs.
  • Flexible and Scalable
    The technology supports flexible batch sizes and is easily scalable, allowing rapid adaptation to different production volumes and straightforward tech transfer between manufacturing sites.
  • Improved Stability
    Since the API is stored in a solid state until the propellant is added, there is reduced risk of sedimentation or aggregation compared to traditional pMDI suspensions.

Advantages for Formulators

  • Simplified Composition
    Respitab combines the active pharmaceutical ingredient (API) and excipients into a single, compressed tablet, eliminating the need for complex suspension formulations.
  • Precise Dose Uniformity
    Each tablet contains a pre-measured, consistent dose of drug and excipients, ensuring reliable delivery with every actuation.
  • Enhanced Stability
    Storing the API in solid tablet form until propellant addition reduces the risk of sedimentation or aggregation, improving formulation stability over time.
  • Reduced API Loss
    The tablet-based approach minimizes drug loss during manufacturing, cleaning, and filling, which is especially valuable for costly or potent compounds.
  • Flexible for New Propellants
    Respitab is compatible with both traditional and next-generation, low-GWP propellants, supporting regulatory and environmental goals.

Propellant Dispersible Tablets

Advantages for Manufacturers

  • Streamlined Production
    Tablets are manufactured using standard tablet presses and simply dropped into canisters, eliminating the need for high-shear mixing, homogenization, and continuous agitation required for conventional pMDIs.
  • Reduced Equipment & Cleaning
    The process requires less specialized equipment and results in lower cleaning and validation burdens, saving time and operational costs.
  • Minimized Cross-Contamination
    Individual tablet dosing reduces the risk of cross-contamination between batches, supporting quality assurance and regulatory compliance.
  • Easy Scale-Up & Tech Transfer
    The straightforward tablet process is easily scalable and transferable between manufacturing sites, enabling rapid adaptation to changing project needs.
  • Supports Rapid Development
    The simplicity and flexibility of the Respitab process allow for faster formulation optimization and quicker progression from development to clinical and commercial manufacturing.

Key Advantages

Low Cost

Product development can be conducted at small scale. Low risk of batch failure at final product stage.

Simple Scale Up

No complex processes requiring costly scale up.

Fast

Formulation development is quick as can largely be done at lab scale with low risk scale up.

Platform Technology

Simplified development as same technology used as a platform across multiple products.

Tunable

Formulations can be tuned to optimize product performance.

Approved Excipients

Excipients well established in major markets for inhalation products.

Patent Protected

Approved patents in major markets.

Flexibility

Process can be continuous or discontinuous allowing intermediates to be shipped to other locations for filling.

Example

Respitab Salbutamol APSD after storage at 40°C/75%RH at 0, 1, 3 and 6 months Ventolin comparator is from a UK pharmaceutical wholesale supplier

Respitab Salbutamol Accelerated Stability Performance