SPI Pharma – Streamlining ODT technology
Developing orally disintegrating tablets can be expensive due to their complex dosage forms. Two platforms are available that aim to improve the manufacturing process.
An orally disintegrating tablet (ODT) is a tablet that when placed in the mouth, usually on the tongue, disintegrates without the aid of water in less than 60 seconds. SPI Pharma offers two distinct platforms to facilitate the formulation of ODTs – Pharmaburst and Pharmafreeze. In addition, SPI Pharma provides a taste-masking encapsulation technology to work in conjunction with these two platforms, Pharmacaps, which masks the bitter taste of APIs.
Pharmaburst is an engineered co-processed excipient system, which is used as a quick disintegrating matrix in the manufacture of ODT using standard manufacturing equipment and packaging lines. ODTs are generally manufactured by dedicated companies that have specialised manufacturing and packaging equipment because of the complexities of the dosage form, such as low tablet hardness and high friability. Naturally, high costs and fees are then associated with this approach.
Pharmaburst allows the customer to keep control of the formulation development process because its ODT products can be developed in the customers’ facility with standard tablet presses and tooling. The resultant tablets are very robust with low friability and fast disintegration, allowing packaging into blisters or bottles using standard packaging equipment.
Pharmaburst has a US DMF and Australian TGA registration. All the ingredients used in this system meet one or more of the following monographs: USP, NF, EP and JP. The details relating to the manufacturing process and the ratios are proprietary. The patent is expected to be issued by October 2006.
Pharmaburst products include:
- Dimenhydrinate – used for motion sickness
- Acetaminophen – used as an analgesic for children
- Mirtazapine – an antidepressant
- Sublingual B-12
SPI Pharma, in conjunction with an exclusive partner, provides an innovative platform for pharmaceutical applications using lyophilisation (freeze-dried) technology. This technology enables the manufacture of ODTs (wafers) that dissolve in less than five seconds. The advantages of the patented process (Patent No. 5,298,261) include a more robust matrix than competitor formulation, such as:
- Maximises tablet strength per volume ratio
- Controlled collapse during drying prepares a denser, yet quick dissolving tablet
- Less hygroscopicity or sensitivity to moisture
- Maximises tablet strength for handling, shipping and storage
Higher API loading vs competitor, such as:
- 1mg to 250mg/tablet at 1.0ml fill volume, with other volume fills available
- Dosage flexibility with SPI taste-masking technology (Pharmacaps)
- Suitability for sublingual, gastrointestinal and rectal delivery of actives
The drying process helps to preserve the form and functionality of the API and excipients after drying. SPI Pharma can also provide contract services for the freeze-dried process, which meet CGMP compliance. Contract services include formulation development, testing and commercial manufacturing.
Quick dissolving tablets
With over 40 years of experience in designing and operating lyophilisers, SPI will optimise formulation and conduct ICH testing if desired for tablet production capacity: 13,040 tablets per lot. Proven applications include:
- Therapeutic Peptide (status: phase 1 and 2)
- Herbal extracts (status: R D)
SPI Pharma develops custom-formulated solutions for the pharmaceutical and nutraceutical manufacturers. SPI Pharma is a subsidiary of Associated British Foods, which is based in the UK and has sales of over $8bn.
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