G Model IJP 13917 No. of Pages 3
International Journal of Pharmaceutics xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Pharmaceutics journal homepage: www.elsevier.com/locate/ijpharm
The place of dosage form innovation and the OTC market: The price to pay Paul L. Goggin * Pfizer Consumer Healthcare, 32 Dumpton Park Drive, Broadstairs, Kent CT10 1RQ, UK
A R T I C L E I N F O
A B S T R A C T
Article history: Received 24 February 2014 Accepted 24 February 2014 Available online xxx
Aims and Objectives: The aims and objectives of this article are to provide a background to the innovations that are made in over the counter market and to outline the time and costs involved in these activities. ã 2014 Elsevier B.V. All rights reserved.
Keywords: Dosage form innovation OTC market Price to pay
Many of the large pharmaceutical companies have invested in consumer healthcare businesses. These organisations focus on providing medicines for adults and children for the treatment and relief of minor ailments e.g. athlete’s foot or headaches. These products are often provided through pharmacies either for self selection or as a result of healthcare advice. One of the most noteworthy aspects of these products is in their evolution and life cycle management. There are many examples of innovation in terms of both dosage form and packaging design (see Fig. 1). The reason for this is based on the highly competitive nature of the industry. Pressure is exerted by competitor OTC and private label companies who supply drug stores and supermarkets with generic versions of these medicines. In addition to efforts on managing the product life cycle, proprietary pharmaceutical companies are investing significant time and effort into new therapeutic areas within the OTC space An extremely good example of the application of different delivery systems is within the provision of nicotine replacement therapy (see Fig. 2). In the earlier days, nicotine was delivered by using chewing gum as the delivery medium. This not only delivered the alkaloid but also provided distractions to the habits and rituals associated with smoking. These products were not ideal and took a degree of mandibular skill to deliver nicotine at the right rate and without side effects. As a consequence delivery could be too fast or too slow, leading to different outcomes in response by the user. As time progressed this category saw the development of patches, providing steady state dosing of
* Corresponding author. Tel.: +44 1304640692. E-mail address: paul.goggin@pfizer.com (P.L. Goggin).
nicotine, with further evolution to clear and smaller patches to improve discretion. Following on, products such as insufflators were developed to provide a rapid rise in blood levels and eventually this was achieved using nasal sprays. Specialised lozenge products have been added to the anti-smoking armoury. This has provided a range of pharmacokinetic solutions to the issues with providing addicts with both instant relief and steady state for their cravings. Finally we have seen the rise of the electronic cigarette and its regulation to provide a further option in harm reduction. For children’s medicines, many advances have also been made. Innovations have included, products that are provided as an acceptable tasting suspension e.g. paracetamol. The evolution has included fast melt tablets, which provide a without water convenience (Mrsny, 2012). Individual sachets of syrup to avoid measuring the product out and even products where the flavour can be added at the time of dosing. Again these products give the consumer choice and allow a degree of personalisation. Innovation in this area has to be carefully considered, because of the line between medicine and confectionary, so while improving compliance and adherence is critical making these products too attractive to minors is also an important consideration. The reasons for these types of product enhancement are all around competitive edge and staying ahead of the competition. It is important the product confers an advantage and the key drivers are improved compliance, improved convenience and to provide an improved or tailored PK profile. Providing safe and effective, easy to use medicines that work quickly to provide relief over the short term is a key driver. In addition building trust in a brand is vital to its survival and requires constant nurturing to achieve the desired outcome. This is even more critical with products for
http://dx.doi.org/10.1016/j.ijpharm.2014.02.042 0378-5173/ ã 2014 Elsevier B.V. All rights reserved.
Please cite this article in press as: P.L. Goggin, The place of dosage form innovation and the OTC market: The price to pay, Int J Pharmaceut (2014), http://dx.doi.org/10.1016/j.ijpharm.2014.02.042
G Model IJP 13917 No. of Pages 3
2
P.L. Goggin / International Journal of Pharmaceutics xxx (2014) xxx–xxx
Fig. 1. How do we bring products to the Market.
Fig. 2. Nicotine Product evolution.
children, as parents are putting their trust in the product for their family and consequently expect products of a very high standard. In addition it is important to create some barriers to the competition and this can be done by the use of patents or by creating know-how. It is important that there is a partnership between R and D and marketing, the former often suggesting solutions and the latter driving the need for innovation. In order to support and understand what consumers are looking for in products, leading OTC companies, spend considerable time, effort and money in research. The heart of product innovation is consumer driven and capturing information both qualitatively, i.e. What do people want and quantitatively i.e. will they be prepared to pay for it is key to the future success of any product. Consumer testing has become very sophisticated with investment in many different areas. This has including building facilities that mimic the home environment to observe how consumers use and interact with a product. Consumers can be observed and recorded during product concept testing and a detailed analysis can be made of their response to a particular product. All aspects of the product from colour, taste, ease of opening, child resistance etc. can be observed and used to help inform the project team of the direction they are going in. In addition field work is also carried out within stores, where demonstrations can be carried out again to look at how consumers interact with a product and to record reactions to it.
In order to build a successful product there is a substantial financial investment required. Costs are many fold and come from many different sources. Typically building innovation requires a number of stages and costs generally increase with each stage. The initial stage is feasibility both from an R and D and commercial perspective. Is the innovation technologically possible and is there any commercial interest in developing the concept. Finding the technological solution requires either an internal solution or the acquisition of an enabling technology to provide that solution. Internal solutions have the advantage of being owned and controlled by the originator; often a solution used in another product category can be the answer to this. Developing solutions from a concept, takes a little more time and may not fit with the commercial drive. Committing to internal innovation is no small undertaking and costs time and money and may not always be successful. External solutions provide different challenges and opportunities. Well developed technologies, especially where there are already examples in the market, allow a rapid assessment of a molecule and the suitability of the delivery format. Feasibility studies are relatively inexpensive and can establish proof of concept, without taking up too much internal R and D time. However as the development progresses, expenditure increases and there are licensing and development costs to be considered. In addition there are often protracted negotiations about the rights to any intellectual property that arise during such developments. For early stage technologies there are potentially a lot of risks and care needs to be taken in weighing up the novelty of a solution versus the time, cost and effort needed to develop the technology for the market. Consideration needs to be given to the regulatory acceptability of a particular approach and any clinical work that would be needed to demonstrate both safety and efficacy. Clinical studies tend to be relatively expensive and again care and consideration is required in their design and execution. New technology whether it comes from internal or external sources will also have considerable costs in developing production scale equipment to make commercial batches. This is a significant undertaking for any organisation and must also be factored in. Other costs for the development of innovative products that must also be accounted for include, any consultation fees, particularly around defining and testing the market, good and well thought out research can save a lot of time and effort in determining the viability of an idea. Patent costs must also be considered when intellectual property is developed for a product. This will include agency and filing costs as well as onward maintenance and defence of IP. Innovation in the OTC market is a necessary part of product life cycle management. It should be tailored to the needs of consumers and requires attention to detail in its execution. As described there is a lot of activity that needs to be undertaken in order to successfully launch a new product, be this line extension or a whole new product concept. The costs involved in these endeavours are high and there is an element of risk, either from a technology or commercial perspective. Each stage needs to be carefully planned out; costs and timings need to factor in all of the area described above. There needs to be a high level of management support for a particular proposition and extreme attention to detail in providing the desired product. Above all the product needs to meet the needs of the consumer, it must re-enforce the trust a person has in the product and must convey advantages to the consumer that are worth the cost at shelf. Successful innovations have been game changing for both companies and for consumers. These innovations are rare and do not happen by accident. They take, time effort and patience but done well are off true value for what they teach, for the knowledge they increase and for the wider society they serve.
Please cite this article in press as: P.L. Goggin, The place of dosage form innovation and the OTC market: The price to pay, Int J Pharmaceut (2014), http://dx.doi.org/10.1016/j.ijpharm.2014.02.042
G Model IJP 13917 No. of Pages 3
P.L. Goggin / International Journal of Pharmaceutics xxx (2014) xxx–xxx
The OTC market has seen many more innovations than the prescription market in terms of life cycle management initiatives (Ellery Hansen, 2012). However these product enhancements have filtered into the mainstream pharmaceutical products and have improved compliance and convenience for the treatment of more serious conditions. The product evolution has taken time but the knowledge gained in the consumer space have been invaluable in improving how medicines are utilised.
3
References Ellery Hansen, A.N., 2012. Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand. John Wiley and Sons Inc., New York, ISBN: 978-0-47048753-2. Mrsny, R.J., 2012. Oral drug delivery research in Europe. Journal of Controlled Release 161, 247–253.
Please cite this article in press as: P.L. Goggin, The place of dosage form innovation and the OTC market: The price to pay, Int J Pharmaceut (2014), http://dx.doi.org/10.1016/j.ijpharm.2014.02.042
International Journal of Pharmaceutics xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Pharmaceutics journal homepage: www.elsevier.com/locate/ijpharm
The place of dosage form innovation and the OTC market: The price to pay Paul L. Goggin * Pfizer Consumer Healthcare, 32 Dumpton Park Drive, Broadstairs, Kent CT10 1RQ, UK
A R T I C L E I N F O
A B S T R A C T
Article history: Received 24 February 2014 Accepted 24 February 2014 Available online xxx
Aims and Objectives: The aims and objectives of this article are to provide a background to the innovations that are made in over the counter market and to outline the time and costs involved in these activities. ã 2014 Elsevier B.V. All rights reserved.
Keywords: Dosage form innovation OTC market Price to pay
Many of the large pharmaceutical companies have invested in consumer healthcare businesses. These organisations focus on providing medicines for adults and children for the treatment and relief of minor ailments e.g. athlete’s foot or headaches. These products are often provided through pharmacies either for self selection or as a result of healthcare advice. One of the most noteworthy aspects of these products is in their evolution and life cycle management. There are many examples of innovation in terms of both dosage form and packaging design (see Fig. 1). The reason for this is based on the highly competitive nature of the industry. Pressure is exerted by competitor OTC and private label companies who supply drug stores and supermarkets with generic versions of these medicines. In addition to efforts on managing the product life cycle, proprietary pharmaceutical companies are investing significant time and effort into new therapeutic areas within the OTC space An extremely good example of the application of different delivery systems is within the provision of nicotine replacement therapy (see Fig. 2). In the earlier days, nicotine was delivered by using chewing gum as the delivery medium. This not only delivered the alkaloid but also provided distractions to the habits and rituals associated with smoking. These products were not ideal and took a degree of mandibular skill to deliver nicotine at the right rate and without side effects. As a consequence delivery could be too fast or too slow, leading to different outcomes in response by the user. As time progressed this category saw the development of patches, providing steady state dosing of
* Corresponding author. Tel.: +44 1304640692. E-mail address: paul.goggin@pfizer.com (P.L. Goggin).
nicotine, with further evolution to clear and smaller patches to improve discretion. Following on, products such as insufflators were developed to provide a rapid rise in blood levels and eventually this was achieved using nasal sprays. Specialised lozenge products have been added to the anti-smoking armoury. This has provided a range of pharmacokinetic solutions to the issues with providing addicts with both instant relief and steady state for their cravings. Finally we have seen the rise of the electronic cigarette and its regulation to provide a further option in harm reduction. For children’s medicines, many advances have also been made. Innovations have included, products that are provided as an acceptable tasting suspension e.g. paracetamol. The evolution has included fast melt tablets, which provide a without water convenience (Mrsny, 2012). Individual sachets of syrup to avoid measuring the product out and even products where the flavour can be added at the time of dosing. Again these products give the consumer choice and allow a degree of personalisation. Innovation in this area has to be carefully considered, because of the line between medicine and confectionary, so while improving compliance and adherence is critical making these products too attractive to minors is also an important consideration. The reasons for these types of product enhancement are all around competitive edge and staying ahead of the competition. It is important the product confers an advantage and the key drivers are improved compliance, improved convenience and to provide an improved or tailored PK profile. Providing safe and effective, easy to use medicines that work quickly to provide relief over the short term is a key driver. In addition building trust in a brand is vital to its survival and requires constant nurturing to achieve the desired outcome. This is even more critical with products for
http://dx.doi.org/10.1016/j.ijpharm.2014.02.042 0378-5173/ ã 2014 Elsevier B.V. All rights reserved.
Please cite this article in press as: P.L. Goggin, The place of dosage form innovation and the OTC market: The price to pay, Int J Pharmaceut (2014), http://dx.doi.org/10.1016/j.ijpharm.2014.02.042
G Model IJP 13917 No. of Pages 3
2
P.L. Goggin / International Journal of Pharmaceutics xxx (2014) xxx–xxx
Fig. 1. How do we bring products to the Market.
Fig. 2. Nicotine Product evolution.
children, as parents are putting their trust in the product for their family and consequently expect products of a very high standard. In addition it is important to create some barriers to the competition and this can be done by the use of patents or by creating know-how. It is important that there is a partnership between R and D and marketing, the former often suggesting solutions and the latter driving the need for innovation. In order to support and understand what consumers are looking for in products, leading OTC companies, spend considerable time, effort and money in research. The heart of product innovation is consumer driven and capturing information both qualitatively, i.e. What do people want and quantitatively i.e. will they be prepared to pay for it is key to the future success of any product. Consumer testing has become very sophisticated with investment in many different areas. This has including building facilities that mimic the home environment to observe how consumers use and interact with a product. Consumers can be observed and recorded during product concept testing and a detailed analysis can be made of their response to a particular product. All aspects of the product from colour, taste, ease of opening, child resistance etc. can be observed and used to help inform the project team of the direction they are going in. In addition field work is also carried out within stores, where demonstrations can be carried out again to look at how consumers interact with a product and to record reactions to it.
In order to build a successful product there is a substantial financial investment required. Costs are many fold and come from many different sources. Typically building innovation requires a number of stages and costs generally increase with each stage. The initial stage is feasibility both from an R and D and commercial perspective. Is the innovation technologically possible and is there any commercial interest in developing the concept. Finding the technological solution requires either an internal solution or the acquisition of an enabling technology to provide that solution. Internal solutions have the advantage of being owned and controlled by the originator; often a solution used in another product category can be the answer to this. Developing solutions from a concept, takes a little more time and may not fit with the commercial drive. Committing to internal innovation is no small undertaking and costs time and money and may not always be successful. External solutions provide different challenges and opportunities. Well developed technologies, especially where there are already examples in the market, allow a rapid assessment of a molecule and the suitability of the delivery format. Feasibility studies are relatively inexpensive and can establish proof of concept, without taking up too much internal R and D time. However as the development progresses, expenditure increases and there are licensing and development costs to be considered. In addition there are often protracted negotiations about the rights to any intellectual property that arise during such developments. For early stage technologies there are potentially a lot of risks and care needs to be taken in weighing up the novelty of a solution versus the time, cost and effort needed to develop the technology for the market. Consideration needs to be given to the regulatory acceptability of a particular approach and any clinical work that would be needed to demonstrate both safety and efficacy. Clinical studies tend to be relatively expensive and again care and consideration is required in their design and execution. New technology whether it comes from internal or external sources will also have considerable costs in developing production scale equipment to make commercial batches. This is a significant undertaking for any organisation and must also be factored in. Other costs for the development of innovative products that must also be accounted for include, any consultation fees, particularly around defining and testing the market, good and well thought out research can save a lot of time and effort in determining the viability of an idea. Patent costs must also be considered when intellectual property is developed for a product. This will include agency and filing costs as well as onward maintenance and defence of IP. Innovation in the OTC market is a necessary part of product life cycle management. It should be tailored to the needs of consumers and requires attention to detail in its execution. As described there is a lot of activity that needs to be undertaken in order to successfully launch a new product, be this line extension or a whole new product concept. The costs involved in these endeavours are high and there is an element of risk, either from a technology or commercial perspective. Each stage needs to be carefully planned out; costs and timings need to factor in all of the area described above. There needs to be a high level of management support for a particular proposition and extreme attention to detail in providing the desired product. Above all the product needs to meet the needs of the consumer, it must re-enforce the trust a person has in the product and must convey advantages to the consumer that are worth the cost at shelf. Successful innovations have been game changing for both companies and for consumers. These innovations are rare and do not happen by accident. They take, time effort and patience but done well are off true value for what they teach, for the knowledge they increase and for the wider society they serve.
Please cite this article in press as: P.L. Goggin, The place of dosage form innovation and the OTC market: The price to pay, Int J Pharmaceut (2014), http://dx.doi.org/10.1016/j.ijpharm.2014.02.042
G Model IJP 13917 No. of Pages 3
P.L. Goggin / International Journal of Pharmaceutics xxx (2014) xxx–xxx
The OTC market has seen many more innovations than the prescription market in terms of life cycle management initiatives (Ellery Hansen, 2012). However these product enhancements have filtered into the mainstream pharmaceutical products and have improved compliance and convenience for the treatment of more serious conditions. The product evolution has taken time but the knowledge gained in the consumer space have been invaluable in improving how medicines are utilised.
3
References Ellery Hansen, A.N., 2012. Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand. John Wiley and Sons Inc., New York, ISBN: 978-0-47048753-2. Mrsny, R.J., 2012. Oral drug delivery research in Europe. Journal of Controlled Release 161, 247–253.
Please cite this article in press as: P.L. Goggin, The place of dosage form innovation and the OTC market: The price to pay, Int J Pharmaceut (2014), http://dx.doi.org/10.1016/j.ijpharm.2014.02.042
