Company insight Small size, big impact
Small molecule drugs have stood the test of time as the preeminent pharmaceutical method for treating patients. What this also means is that competition in the space is fierce, and every advantage matters – both in terms of manufacturing costs and product performance. Bill McCarthy, director of marketing at SPI Pharma, explains how the company’s S-Tab tablet platform offers both of these advantages, as well as enabling companies to bring products to market and scale them faster.
What is the S-Tab Pre-formulation platform? The S-Tab tablet platform is an excipient pre- formulation platform based on the excipients mannitol and MCC (microcrystalline cellulose). It is designed to quickly create tablets with improved compatibility, flowability and stability. This advantage not only streamlines transfer to manufacturing, but also contributes to cost savings by minimising the need for multiple changes in formulation at the development stage.
What sort of clients would benefit from the use of the platform? Anyone that would like to quickly develop tablets by direct compression would benefit from the ability of this product to speed development and scale up their manufacturing. Companies working with high-cost active pharmaceutical ingredients (APIs), where high speed tableting with a low failure rate could improve profit potential, are a main target for S-Tab. Customers working with APIs that have degradation issues, specifically Maillard interactions, could also benefit. Additionally, any formulators that have limited resources and would benefit from accelerating product development should be developing with S-Tab. Since it is a pre- formulation, it ensures the right proportion of excipient ingredients and compatibility. The composition of S-Tab does not include copovidone, crospovidone or povidone, so its potential to create nitrosamine contamination is significantly reduced versus other competitive tablet platforms that do include these materials.
How does the platform work, and what benefits does it offer to these clients?
The platform enables very high-speed direct compression and combines it with very low defect rates, essentially creating
more sellable tablets with each production run, which allows customers to sell more tablets for each run – boosting their profitability. For example, a manufacturer that runs a batch of 1,000,000 tablets that he can sell for $0.50/tablet using a normal formulation could have a defect rate of up to 1%, resulting in 10,000 tablets being discarded and 990,000 tablets sold for each batch. S-Tab can reduce the defect rate to 0.2% – which means only 2,000 tablets are discarded and 8,000 additional tablets are available to be sold versus the standard material.
Expensive APIs can potentially sell for $0.50 or more, so in this example the revenue for the batch increases by $4,000 when using S-Tab. This value is incremental to the savings offered by reduced waste from a more productive operation.
How does bringing the S-Tab platform to market complement the services already offered by SPI Pharma?
SPI has a long history of providing pre- formulation platforms to the oral solid dose market, and our expertise in optimising tablets powers the performance of this new product. We design our products for performance, not to simply sell our excipients, and this focus results in higher performance versus competitive materials. SPI also creates value by providing its formulation expertise to customers. We can support S-Tab by being ready to bring prototypes to our customers. After discussing their project, we can demonstrate how quickly our products can be deployed to meet their needs, and to discuss creative ways to help accelerate development and meet formulation requirements.
Do you have any examples to show how the platform meets the
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
needs of clients in the marketplace? We have several use cases showing examples of the robust tablets that can be created using S-Tab. Additionally, we have a high-speed tableting study showing the performance of our material at levels that were remarkable even to a tablet equipment manufacturer. During our development of S-Tab, we ran high-speed trials to validate the performance in application. The tablet press maker generously hosted us at their facility. We ran the tablet press at maximum speed and measured the observed failure rate versus a standard lactose formulation. The failure rate was 10 times lower using S-Tab and, as a result, the machine makers asked us if they might use the platform to show their customers how well their machine runs at high speed. Since S-Tab has extremely good flow, we found that it can be useful in capsule operations, where good flow is essential to ensure content uniformity and rate while filling capsules. Excellent flow was identified as a feature that S-Tab had to have for direct compression as it applies across solid-dose formulation.
How does SPI Pharma differentiate its platform from other pre- formulation platforms for tablets on the market?
This platform is specifically designed for tablet performance and high-speed productivity. It’s differentiated by its ability to create robust tablets, faster, across a wider variety of APIs in comparison to the competition. Although it is Mannitol-based, S-Tab was not developed to pull through a specific set of materials; it was designed to create an optimal tablet platform with SPI’s decades of experience. ●
www.spipharma.com 37
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61
