Stability Testing        Industry OverviewPharma IQ Sector Report & Resources:     Interviews with Industry Experts       ...
Contents                                  3        Getting to Grips with Stability Testing and Regulatory                 ...
Getting to Grips with Stability Testing and Regulatory Compliance  Find out more about the challenges in pre-and post-rele...
Getting to Grips with Stability Testing and Regulatory Compliance  Pharma IQ: There is a lot of hype in the market about Q...
Getting to Grips with Stability Testing and Regulatory Compliance  Pharma IQ: Please can you explain some of the different...
Stability Data in the Cold Chain  Cornelia Nopitsch-Mai, scientist for the Federal Institute for Drugs and Medical Devices...
Predicting Physical Stability of Amorphous Solid Dispersions  Stéphanie Greco, Analyst Scientist, Pharmaceutical Science D...
Predicting Physical Stability of Amorphous Solid Dispersions  There are several criteria that are important to discriminat...
3 Tips on Overcoming Poor Aqueous Solubility and Stability  Rene Holm, Head of Preformulation at H Lundbeck A/S, joins Pha...
3 Tips on Overcoming Poor Aqueous Solubility and Stability  Pharma IQ: How exactly is the industry seeking to overcome the...
Additional ResourcesINTERVIEWEstablishing an Effective and Efficient Stability Testing ProgrammeWith Shekhar Natarajan, Se...
No travel costs, no time out of the office, flexible learning for your whole team!Stability Testing Training Online 2011Ac...
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Stability Testing - 2011 Pharma IQ Resource Pack

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Industry Overview
Pharma IQ Interviews & Resources June 2011

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  1. 1. Stability Testing Industry OverviewPharma IQ Sector Report & Resources: Interviews with Industry Experts June 2011 In Association With STABILITY TESTING Pharma IQ Resource Pack 2011
  2. 2. Contents 3 Getting to Grips with Stability Testing and Regulatory Compliance 6 Stability Data in the Cold Chain 7 Predicting Physical Stability of Amorphous Solid Dispersions 9 3 Tips on Overcoming Poor Aqueous Solubility and Stability 11 Additional Resources 12 Stability Testing Training Online 2011Authors: Andrea Charles & Helen Winsor Pharma IQ 2010 - 2011 STABILITY TESTING Pharma IQ Resource Pack 2011
  3. 3. Getting to Grips with Stability Testing and Regulatory Compliance Find out more about the challenges in pre-and post-release stability testing and formulation. In this Pharma IQ interview, Claire Willsher, head of analytical development at Lifecycle Pharma, discusses the technologies being employed by Lifecycle Pharma to pre-empt these challenges. Willsher also offers her perspective on Quality by Design, cost-cutting and how to achieve regulatory compliance. Pharma IQ: So, Claire, just to start off, where do you think the main challenges are in pre-stability testing at the moment? C Willsher: I think the main challenge at the moment in pre-stability testing is the fact that we tend to focus a lot on chemicals, for the chemical side, for the chemical stability. And we don’t really look at the physical attributes so much in pre-stability. And I think that this is an area that we really need to work on. We need to work hard to look at polymorph and active pharmaceutical ingredients (APIs), excipients, etc, and that kind of thing. And I think that that’s the main challenge at the moment. Pharma IQ: What are the key challenges in stability testing and formulation, and also, what technology do you employ in order to pre-empt these different challenges? C Willsher: Challenges in stable formulation, making a stable formulation - that’s a challenge in itself - or, in reality, the key challenge. So, identify your most stable formulation as early as possible during development. We want to do this to avoid formulation changes at a later stage, that can lead to really costly bioequivalent studies. So, during formulation of your products, it’s important to identify early on compatible excipients; and know the degradation pathways, so that you understand your API as much as possible, then that way you can identify the best formulation routes and initiate any stabilising compounds where you can see that there may be possibility issues. There are a number of tools available for you to look at this kind of thing, and I think those utilised most are forced degradation of excipient compatibility and stability as early as possible. One thing again I’d comment on is to remember to monitor both the chemical and physical attributes, especially when you’re using fluid systems. As I said, we tend to focus on the chemical stability, and it can lead to some not-so-nice surprises at a later stage. To do those kinds of things, obviously you need have an effective chromatography system in place. It needs to be a stability indicating method. At the early stages, it doesn’t have to be as vigorously qualified as it does at later stages, but you still want to ensure that you can monitor all impurities and get reliable results. All the challenges include the normal cost versus stage of development, return on number of samples – that kind of thing. And when to perform those kind of analysis varies from company to company. The use of ultra high pressure liquid chromatography and improved common chemistry nowadays means that sample volume is becoming less of an issue. I think in research and development it’s always going to come down to where we can get the most information for the smallest cost, both monetary and resource. What we do have to remember is that we need to be disciplined and avoid the temptation to say, oh well, it’s not so stable, but we can do something about the packaging to do that. We need to choose our most stable formulation; it might not always be the nicest formulation, but I think the best companies, they have the best decision-making skills, and they’re not afraid for the quick-kill approach. STABILITY TESTING Pharma IQ Resource Pack 2011
  4. 4. Getting to Grips with Stability Testing and Regulatory Compliance Pharma IQ: There is a lot of hype in the market about Quality by Design throughout the product lifecycle. Now, specifically within stability testing, is Quality by Design something that you think will provide benefit? C Willsher: Quality by Design - or QbD, as we know it - is the new buzzword. The authorities undergo cutbacks just like the rest of us. They’re looking for features that can assist them and make their lives easier - something that we all do. I can see the benefits within manufacturing of employing Quality by Design or PAT testing; however, specifically within stability, I’m not so sure that it’s something new that will revolutionise the way that we do things. If you look at what is QbD really, it’s a way of looking at factorial design of experiments, and using your scientific knowledge to ensure that your product quality is maintained, and what you’re putting in is a quality product. However, if you look at ICH (International Conference on Harmonisation) guidelines, in particular Q1D, this discusses how to utilise bracketing and matrixing to minimise the amount of samples required to gain your maximum amount of knowledge about your product. This guidance has been around for nearly a decade or so now. I’m not sure how that differs from the description of what Quality by Design is. I think within stability, we’re already doing Quality by Design as much as possible. If you took the absolute description of Quality by Design to its absolute maximum extent, you perform the majority of your stability on scientific knowledge: one strength may be a couple of pack configurations, tutorial designers, five or six strengths in three or four pack configurations. Do we really think that the authorities are going to approve our product? So, I don’t know if it’s true. I’m not sure that Quality by Design is something that’s going to be new and revolutionise the way we do things in stability. Pharma IQ: What are the main challenges in maintaining regulatory compliance for post-approval pharma products? C Willsher: I think there are a number of challenges in post-approval compliance, and I think that many of them are area-specific; whether it be chemistry, manufacturing and control or clinical, we have different challenges. One of those that a lot of people trip up on is the constant improvement of analytical technology, and everybody wants to be cutting-edge. If it’s not broken, don’t fix it. It’s not always a great idea to constantly change your methods or your processes just to keep up with the new trend. However I think for me, personally, what I find the most challenging is classifying what is a major change, what is a moderate change, what is a minor change to the product, and then how to handle that change with respect to your filing or contacting the authorities. Both the Food and Drug Administration and the European Medicines Agency do have a general description of what the changes should be classified as in their guidance for post-approval requirements; however, these descriptions are a little vague and they’re not very specific. So, that’s where I find the most challenge. STABILITY TESTING Pharma IQ Resource Pack 2011
  5. 5. Getting to Grips with Stability Testing and Regulatory Compliance Pharma IQ: Please can you explain some of the different approaches you have used in the past to achieve constant compliance? C Willsher: I think the simplest thing that you can use is a good change control system. Other valuable tools, I found, are REMS – the risk mitigation evaluation strategy – the use of decision trees to lead to creations and documentation evaluations, and finally, the actual implementation of the change, I think, helps in many situations. There’s one thing that I really like about this process – and it’s really interesting and often very inspiring – it’s the meeting of minds from different viewpoints. Often in these processes you have representation from a number of different departments or specialities, and it could be really interesting to see how the different people from the different viewpoints can brainstorm and bring things forward that you don’t necessarily see or you hadn’t even thought about. I’m not saying it’s always easy, but it definitely helps that process along. Again, the final piece of that process - the implementation of the change - is eased along by a good change control system. I’m sure there are very many other valuable tools out there, and I think the ideal one is to find something that works for you. Pharma IQ: Obviously at the moment stability testing is an area where there are a lot of cost-cutting pressures. What do you see as areas where you can cut costs and what different measures can you take? C Willsher: I think in today’s financial climate with big company mergers and small biotechs folding under the strain of cost-cutting, it’s part of everyday life. When you compare the cost of a phase three clinical trial to the corresponding stability support or primary stability, the cost concerned with stability, it’s a drop in the ocean. However, it’s often the stability that is the place where you have to find ways to save money. To maximise your cost efficiency, you’ve got to look at a number of things, I think, including the possibility of outsourcing large chunks of your studies. Sometimes that gives you advantages compared to utilising the resources you have in-house. Where this may seem contradictory within itself, if you’ve got a good relationship with your contract manufacturing organisation (CMO), then for large amounts of work they’ll provide reasonable rates, especially at the moment. They’re also feeling the effects of this financial climate and they’re also looking for work. One thing I do want to point out here is that there are a number of CMOs being started at the moment in the wake of all these redundancies in the business, where I would say the majority of them are really good. There are an increasing number of not-so-good ones, shall we say. So, I’d say, when you’re outsourcing your stability, cheapest is not always necessarily the best. Also, looking at the quality requirement, and the study that you’re performing, often you can charge less for GMP studies, but still perform according to ISO or GLP, and it’s worth taking advantage of that, if you don’t require full GMP requirement. I’d say that also one of the things that we have to focus on during the lifecycle of development is learning the difference between the nice-to-have and the need-to-have. I’m an analyst, and I know as an analyst, all formulators, they want to put everything onto stability, and one formulator can, on average, create enough work for at least two or three analysts. When your cost-cutting measures are imposed, they’re nice to have if they take on less priority, as much as, myself included, we all hate to go against our scientific interest. We need to leave those exciting, interesting studies behind, and focus on the resource we have, both monetary and time and personnel and on the absolute studies required to move your product towards filing, because at the end of the day we all need to have a return of interest, and to do that, we need our product marketed. STABILITY TESTING Pharma IQ Resource Pack 2011
  6. 6. Stability Data in the Cold Chain Cornelia Nopitsch-Mai, scientist for the Federal Institute for Drugs and Medical Devices in Germany, discusses good distribution practices in cold chain management. To listen to the full interview go to How to Implement Cool Chain Regulations Effectively in Order to Ensure Full Compliance. Pharma IQ: What are the current key initiatives for good distribution practices in cold chain management? C Nopitsch-Mai: I think in this case its the Inspectorate. It doesnt belong to the quality assessment. Its clearly stated that this is the good distribution practice which belongs also to good manufacturing practice and therefore the Inspector has to look for the regulatory issues. Its not a quality issue at that time; it belongs more to the Inspectorate. However, if we can see that something is transported or shipped from lets say one outside Europe, from one climatic zone to another climatic zone, maybe in this case we will ask something about the shipping conditions, but only in these cases and not regularly. Its not a requirement for the quality assessment. Pharma IQ: Regulatory compliance is key; what would be your top tips for implementing cold chain regulations effectively? C Nopitsch-Mai: First its the stability data which supports the need of cold chain transportation and to provide also data at accelerated conditions, lets say for short time, for example at five degrees, and also to provide also data on stress testing, like product stability or data under heat and humidity. Pharma IQ: What are the key stability issues for pharmaceutical bulk products and how should we seek to overcome them? C Nopitsch-Mai: I think its necessary to give details of storage conditions and also on container closure systems, because these are the main issues we have to look for for stability data. So we have the guidelines on stability data on new drug products and new drug substances and also for existing drug substances and drug products. In this guideline no conditions are mentioned for the shipping conditions or cold chain conditions, they are not mentioned or only some parts, some issues are mentioned in these guidelines. But mainly its up to the pharmaceutical company to establish such kinds of conditions and to describe the condition that the bulk- ware, for example, has been stored and also, of course, the container closure system. Pharma IQ: Cornelia, what do you think the future holds for European pharmaceutical cold chain distribution? C Nopitsch-Mai: I think maybe it will become an issue which has to be assessed also by quality assessors and not only by inspectors, so to work closely together with inspectors. I think this may become, in the future, one of the issues regarding stability data. STABILITY TESTING Pharma IQ Resource Pack 2011
  7. 7. Predicting Physical Stability of Amorphous Solid Dispersions Stéphanie Greco, Analyst Scientist, Pharmaceutical Science Department, Sanofi-aventis, joined Pharma IQ to discuss predicting physical stability of amorphous solid dispersions. Pharma IQ: Please could you tell us about your previous achievements and current work at Sanofi- aventis? S Greco: Ive been working for Sanofi for seven years, just after my PhD, and I spent six years in the Physical Quality Service where I was in charge of a laboratory of physical analysis. My main task was to support the teams developing processes of drugs physical treatment, such as milling, micronisation, nano- milling and amorphisation by spray drying. One of my projects has been to actively participate to the development of an amorphous dispersion, and particularly in the screening of a polymer carrier, to improve the stability of this amorphous form. So this project gave me the opportunity to study extensively the physical stability of amorphous dispersions. One year ago I moved to the Pharmaceutical Engineering Service, and Im now developing formulation and processes for extremely poorly-soluble drugs in the nanotechnology domain. For instance, Im specialised in processes like nano-milling or nano-precipitation. Pharma IQ: Commentators have suggested that the number of poorly-soluble drugs on the market is increasing. Why do you think this is? S Greco: Indeed it is one of the most important challenges we are facing in the Pharmaceutical Science department for the development of new drugs. I have heard that 40% of candidates in development are stopped because of the lack of solubility, but it was some years ago, and this number might be under the reality now. Pharma IQ: At the 7th Annual Improving Solubility Summit in June, you are going to be delivering a talk on practical methods to predict physical stability of amorphous solid dispersions. Why did you choose amorphous solid dispersions as a method of improving solubility? S Greco: It is well known for a very long time, that a drug isolated in its amorphous state gets a much higher dissolution rate in water, than its most stable crystalline form. So it seems very interesting to use this property in order to improve the bio availability of poorly-soluble drugs. Unfortunately the development of amorphous drugs was blocked, I think during a long time, because of some technical challenges, such as the poor physical and chemical stability of amorphous compounds. But during the past several years, high improvements have been made to withdraw these technological locks, for example, with the use of a polymer carrier to increase the stability, or the addition of surfactants to improve solubility. And the number of drugs developed as an amorphous form has increased significantly. But the amorphous dispersion is not the only way to increase drugs solubility, for example reducing the drug’s particle size to the nano scale can also give good results. For the project I will present at the conference, in-vivo pharmacokinetic studies demonstrated a better exposure with an amorphous dispersion, compared to the micronised drug or even a nano-suspension. And that was the reason why the amorphous dispersion was the formulation selected for the development of this drug. STABILITY TESTING Pharma IQ Resource Pack 2011
  8. 8. Predicting Physical Stability of Amorphous Solid Dispersions There are several criteria that are important to discriminate different formulation strategies for poorly- soluble drugs, but I think that the direct measurement of bio availability, by in-vivo studies, must always be the crucial point for the final choice. Pharma IQ: What would you say are the main challenges that you face with using amorphous solid dispersions, and how have you overcome them? S Greco: As Ive just said, I think that the main challenge that is usually faced when developing amorphous dispersion is the lack of physical stability of such formulations. Indeed the better solubility is directly linked to the metastability of the amorphous form. An amorphous drug is more soluble because it is less stable. The solution to overcome this problem is well known: it is to make a solid solution between the amorphised drug and an excipient, generally a polymer that is called a polymer carrier. The main role of this polymeric matrix is to prevent the crystallisation of the drug, but not only. During the screening of best polymer carrier for a given drug, it is important to keep in mind that it must be selected according at least three criteria this polymer has to improve the chemical stability of the drug, so there must be a good compatibility between the drug and this polymer. Secondly, it has to improve the long-term physical stability of the drug, since the final amorphous dispersion has to be stable at least two years. At last, it has also to prevent the recrystallisation of the drug in the stomach, or in the gastrointestinal tract, and this can be determined by appropriate in vitro biopharmaceutical tests. It is only when all these criteria are evaluated at the same time that a good choice will be made for the polymer carrier. The process of amorphisation by spray drying can also pose technical difficulties. Handling organic solvents, for instance, in a pharmaceutical environment is not straightforward. It requires double skills between chemical and pharmaceutical areas. So to conclude, the development of amorphous dispersion is a quite complex technology, but all the technical difficulties can find appropriate solutions. STABILITY TESTING Pharma IQ Resource Pack 2011
  9. 9. 3 Tips on Overcoming Poor Aqueous Solubility and Stability Rene Holm, Head of Preformulation at H Lundbeck A/S, joins Pharma IQ to discuss the benefits of early stage preformulation, how advances in drug delivery devices have impacted on formulations, and strategies for enhancing solubility. Pharma IQ: Please could you tell us a bit about your current role? R Holm: I am currently involved in preformulation, both in discovery and development and troubleshooting based on preformulation things in production, and therefore we have a perspective that covers the entire lifecycle of the compound here at Lundbeck. Pharma IQ: Early stage preformulation is a hot topic in formulation development. What are the benefits? R Holm: The benefits of preformulation are to, early on, identify formulation risks; early on help to facilitate and identify a formulation strategy, basically. Those are the two main things. So you need to figure out which strategy to go for and which would work, most probably, and which will not. Furthermore, you need to tell management that you may not be the slacking one here. There may be a scientific reason why this may take longer time. You have to follow the standards, sell the project, perhaps. Preformulation data can actually help with that discussion. Pharma IQ: How have advances in drug delivery devices impacted on formulations? R Holm: On devices, I’m not sure if it has done anything. It has done a lot on pulmonary delivery, but not orally, in my perspective. It’s a more specialised delivery form where it has had any impact. Pharma IQ: And what strategies are companies employing for enhancing solubility? R Holm: In reality, enhancing solubility is not that difficult. You have two main things you can do: either you can increase the solution rate or you can just present it in that form. That can be done by relatively developed strategies. The well-known way of increasing mobility rate is salt formation, but things that are used much more are the solid solution sensation of amorphous form, lipid based formulations, that kind of stuff. But actually it is relatively well described in literature what can be done for these compounds. The tricky thing, of course, is to do it and also to get it in a GP way and in a commercial scale. Pharma IQ: In your view, what are the industrial obstacles to the use of lipid based formulations? R Holm: The main obstacle, as I see it, is encapsability. That’s the one thing. And then solubility in lipids. We would normally use a lipid based formulation where we have a low soluble compound, but there is no link between low… increased solubility and high lipid solubility. So although the compounds are low soluble in water, they may still also have a low solubility in lipids, and we need to solubilise the lipids in order to use that formulation system. Secondly, in the lipids excipients we see impurities that may lead to degradation and oxidation and that encapsability with the compound is also a major. Lipid based formulations really, really possess huge power to increase solubility on those compounds where it works. STABILITY TESTING Pharma IQ Resource Pack 2011
  10. 10. 3 Tips on Overcoming Poor Aqueous Solubility and Stability Pharma IQ: How exactly is the industry seeking to overcome these problems? R Holm: If it’s done right, especially by the excipient deliverance, you can purchase a specialty high purity grade different oils, etc, and that is a way to do it. And then the use of antioxidants, etc. But it is very much to work on the excipient income, in reality, and that’s also what’s been done. Pharma IQ: And how do you plan a robust formulation strategy? R Holm: Quality by design. That’s how we would do it normally. First of all, your formulation strategy will be defined by your preformulation input. The knowledge you have about the compound, its behaviour, its solubilities and its physical parameters, they will define what strategy or strategies you think you’ll go for. Then, to get it robust, at least from a pharmaceutical point of view, you would define a design space and that design space can also be transferred into a clinical design space. That’s normally how we would do it. You would use the thinking and the thoughts that are included in quality by design. Pharma IQ: What would be your top three tips for overcoming poor aqueous solubility instability, Rene? R Holm: The best still is to get a soluble compound. Having said that, I’m well aware that whenever you select a compound in pharmaceutical industries, physical parameters normally has a lower rank than pharmacology. This, of course, makes sense, because if it doesn’t work there’s no need to use the time... Internally, in the company, you need to define what relatively generic strategy can be used for these kinds of compounds – what are we going for. Are we going for solidification of the amorphous form, which can be among the different classes of compounds. At least, I would also consider internally which scientific capabilities we have in-house to produce this. We have to have the equipment so we can do it both on a lab scale and on a GP scale. We don’t need to do it on a high scale level. All we need is to identify inventors that can help us to do that. But we need to find what our priorities are and make the formulations. On solubility it is a bit more tricky because it depends much more what is the instability problem. You need to define the formulation solution to the specific compound, and that is one of the major measures. Look at the compound, look at what you know, and fit the formulation and the work to the compounds. STABILITY TESTING Pharma IQ Resource Pack 2011
  11. 11. Additional ResourcesINTERVIEWEstablishing an Effective and Efficient Stability Testing ProgrammeWith Shekhar Natarajan, Senior Executive-CMC Regulatory Affairs, Johnson & Johnson In this podcast, Shekhar Natarajan, Senior Executive-CMC Regulatory Affairs, Johnson & Johnson discusses current challenges in meeting stability requirements and how to overcome them.VIDEOEuropean Regulatory Guidelines Controlled or AmbientTemperatures, Stability Data and ComplianceWith Ian Holloway, Manager, Defective Medicines Report Centre, Medicines andHealthcare Products Regulatory Agency (MHRA) There is more regulatory interest in ambient products and growing opportunities for solution providers to enter this market. In this presentation Ian Holloway, Manager, Defective Medicines Report Centre, Medicines and Healthcare Products Regulatory Agency (MHRA), discusses the expectations and documenting for ambient or CRT products, regulatory expectations for qualification or validation and stability studies versus shipping studies.VIDEODrug Discovery and the Market Today: Critical Thoughts on StabilityWith Dr. David Elder,Externalization Director,GlaxoSmithKline Dr. David Elder is the Externalization Director for GlaxoSmithKline. Here, he talks exclusively to Pharma IQ on his perspective across the industry, including CROs, regulations, and strategising for efficiency. STABILITY TESTING Pharma IQ Resource Pack 2011
  12. 12. No travel costs, no time out of the office, flexible learning for your whole team!Stability Testing Training Online 2011Access 5 hours of direct learning with a leading industry expert to understand the new ICH guidelines and ensure longterm quality and first time regulatory approvalWith companies worldwide failing to get market access due to insufficient stability data the pressure to ensure thatthe regulatory requirements for stability testing are fulfilled, first time, has never been higher with the pharmaceuticalindustry as a whole focusing on cutting margins and avoiding recalls.ICH has created guidelines to regulate the major markets, however the WHO is pushing to amending those guidelinesin favour of global harmonisation.Coupled with the trend towards global supply chains and working in climatic zones there are many challenges when itcomes to assessing humidity and temperature levels in different supply zones - are you fully prepared for thesechanges?Being involved in stability testing, you are well aware that high standards have to be maintained whilst dealing withsignificant budget and time constraints. Establishing an effective and efficient stability testing programme is key toensuring regulations are upheld whilst staying within your margins.Pharma IQs Stability Training Course has been constructed to give you the tools to achieve this -all at the comfort of your own desk!Secure your spot on the only interactive, online course addressing the ICH guidelines.This offer is available for a limited time!We have 5 interactive modules and for those participants interested in accreditation, we offer an official exam. Thiswill be internet based and available upon completion of the training course. Materials can be completed in your owntime, all of which will arm you with the necessary skills to develop a robust stability testing programme.Train your whole team and save up to €550 per person! Click Here Meet Your Course Leader: Dr Manuel Zahn 3R Pharma Consulting Speaking on: Understanding the Regulatory Aspects of Stability Testing Implementing an Effective Stability by Design Prgramme Evaluation of Stability Data Stability Testing for Global Markets Temperature Monitoring during Shipment STABILITY TESTING View the full Module List Click Here Resource Pack 2011 Pharma IQ

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