How Much Does It Cost To Make A Pharmaceutical Tablet Product?

Posted by David Watt

Find me on:

file7581340932135Pharmaceutical companies frequently ask us this question: how much does it cost to manufacture a pharmaceutical tablet? The real answer is: it depends on many factors. We need to truly understand the detailed specifics of the pharmaceutical company’s objectives and requirements for the product, with respect to manufacturing, packaging, testing, and regulatory submission in order for us to address cost in an intelligent and realistic manner.

Unique Packaging Components Often Mean Purchasing Unique Change Parts

Does your product require specialized packaging components, such as a unique bottle or cap? If this is the case, then specialized packaging change parts will be required to accommodate this unique container closure. This can add cost to the overall product.

A Tablet Can Come In A Variety of Forms and Functions, Which Can Have An Impact On Price

WS-12-2013_80-2The first question from a manufacturing perspective will be the mode of operation of the tablet. This can be best described in that, what is the tablet’s operating mechanism, whether this is an immediate release tablet, modified release, sustained release, bio-adhesive etc. and, will have its own unique formulation and excipients. In general, delayed release tablets can be more expensive due to specialized polymers. Immediate release tablets are, in general, manufactured using direct blend technique (a tumble mix) which is sometimes less costly as it involves less steps and equipment usage. Also, there is no fluid bed drying component.

Modified or controlled release tablets are generally more complex processes which can include high shear granulation and fluid bed drying, which can escalate the manufacturing costs due to multiple work centre usages (more equipment set up and cleans). With compression, the batch size (number of tablets) will dictate run length and therefore cost. Larger batch sizes and longer campaign lengths can reduce cost in many cases.

Complexities, such bilayer tablets, give added costs due to multiple granulations or blend sections to produce each layer separately. Whether a tablet is coated or not can impact the price as well, coating a tablet can add up to an additional 30% more manufacturing hours and thus a greater price.

It Is Important To Know The Environmental Health and Safety Information Of Your Tablet's Active Ingredients

An important consideration to be aware of is Environmental Health and Safety. Each API has its own unique method of action and we need to protect our employees from the hazards. We categorize the API with a safety rating, and we use the necessary containment practices to handle these compounds. The more containment and speciality handling of an API or product, the greater the associated costs.

Analytical Testing Requirements Can Affect Your Tablet Price

WS-12-2013_47-1Speciality analytical testing requirements can significantly impact the price, as new equipment may be required or the use of approved outside testing laboratories. Many tablets have specialized testing regimes such as Atomic Absorption or Multi Stage/Multi Media dissolution profiles.

Giving a tablet cost is difficult; the pharmaceutical company must provide us with a full technical package of documents for us to provide an accurate quotation on the scope of work. The client also must provide an annual forecast along with the regulatory strategy to determine when batches, such as registration, validation and launch batches, will be required.

Download Your Free E-Book Now ››

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.

Find me on:

About The Author