5 Key Factors That Contribute To Price Differences Between Tablets And Creams In Drug Manufacturing

Posted by David Watt

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WPCC_ManufacturingPharmaceutical companies frequently ask us this question when they have a multi-dosage form portfolio they want us to provide a quotation or scope of work on. The answer to this question is multi-faceted in that there are a number of questions with regard to materials, process, and testing requirements that need to answered.   

Armed with those answers, we can examine and factor the responses into a determination of the commercial cost to develop either a tablet or cream process.

 

1. Raw Material Costs Play a Large Role in Price Differences

Let’s first look at the raw material costs between a typical tablet and cream formulation. The formulations are uniquely different.

  • Tablets - typically contain an API, a binder/filler, a disintegrant, a lubricant and in the case of sustained release products, a rate-determining polymer.
  • Creams - typically contain an API (in some cases, multiple APIs) and from 10-15 excipients. These are usually quite specialized; these can be moisturizers, SPF components, viscosity forming polymers, preservative systems, stabilizers and wax components. These items are typically more expensive than the excipients used in a typical tablet formulation.

In general, the raw material costs for a cream are higher than those of a tablet for a similar size batch. Of course there are exceptions - especially when speciality rate-determining polymers/pore forming components are used.

2. Taking A Closer Look at Packaging’s Role in Cost Considerations

To package a cream, we are typically looking at a tube (laminate or metal), a carton, insert, shipper and a shipper label. For a tablet, we usually have a bottle, desiccant, coil, topsert, label, shipper and shipper label.

Unless a speciality item - such as an airless pump system - is required, the increased number of components for tablet packaging typically makes tablet filling slightly more expensive. There are more steps involved in the primary and secondary packaging, including a bottle, desiccant, cotton, cap, induction seal, topsert, label, patient instructions leaflet, carton, shipper and shipper label etc. Also, there is typically more manpower required for the tablets as more steps/operations are involved.

3. Pricing Impact From a Manufacturing Perspective

WS-12-2013_25From a manufacturing perspective, a tablet manufacturing process consists of a granulation/blend, a drying component, sizing and a final blend. This is followed by compression and coating. Tablets utilize more manufacturing centres, meaning that multiple shifts are required for manufacturing, leading to more set-ups and cleaning.

Typically, a cream process is a single suite operation, but there are multiple phase preparations which require ancillary tanks/mixing vessels are (where) oil and water phases are created then combined into the final mixing tank.

In general, a tablet manufacture is a multi-shift/multi centre operation where a cream is usually manufactured in continuous operation lasting between 8-20 hours. A coated tablet will utilize greater manpower and more production suites. Due to the greater number of production suites, there are a greater number of setup and room cleans and changeovers.

4. The Capital Investment Differences between Tablets and Creams

From a capital expenditure perspective, there are typically greater costs associated with tablet manufacture as special tooling and screens will be required; in addition there are associated packaging costs such as slats, brushes and chutes. Specialty equipment such as roller compactors and mills can be of significant cost.

With creams, usually screens are required as are packaging change parts to accommodate tube sizing. Specialty items such as Microfluidizers can be very costly along with the associated diamond chambers.

5. How Quality Assurance Ties In With Pricing

Typically, testing times are going to be similar for tablets and creams. Creams, with the associated micro testing, tend to take longer than typical tablet testing. Quality assurance costs are often similar as batch record review and specification generation will be comparable. With a greater amount of excipients, quality assurance to support creams can be slightly more costly based on the number of specifications required.

In conclusion, it really depends on the material cost, manufacturing/packaging process, and the testing required as to how much the end product costs.

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Topics: Manufacturing Scale-Up

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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