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Oral solid dosage forms are still the most commonly used drug dosage form in the world pharmaceutical industry. Oral solid dosage forms will continue to grow in the near future. This article points out that the major challenge currently affecting drug development in the world is overcoming bioavailability issues. The advantages of accelerated drug development pathways are presented; the importance of a patient-centred dosage form approach when developing a drug product with specific patient populations in mind is presented. Areas to be developed in the near future are forecasted.
As the world’s pharmaceutical research and development programs become increasingly filled with complex molecular drugs, the patient experience becomes more and more important, and research developers look to provide more expertise and solutions. Oral solid dosage forms are still the most commonly used drug dosage form in the world pharmaceutical industry. Oral solid dosage forms will continue to experience market growth in the near future. However, a range of factors, such as the heightened focus on biologics, a higher proportion of poorly soluble molecules in the research and development pipeline, and regulatory development paths, may shift the balance and raise the profile of new innovative dosage forms, increasing the need for specialized skills demand.
The world’s pharmaceutical pipeline is filled with more complex, harder-to-manufacture compounds that require complex dosing strategies to properly control dosage. Demand for technical expertise has skyrocketed, and drug research developers are increasingly looking to outsourced solutions to commercialize their products.
Part 1 Overcoming Bioavailability Issues
A major challenge currently affecting drug development is overcoming the bioavailability issue, which is made more difficult due to the increasing number of complex and poorly soluble molecules that are incorporated into research and development programs. About 40% of the world’s new chemical entities (NCEs) have low water solubility, implying strategies to improve low bioavailability
1.1 There Are Various Techniques To Increase Bioavailability
Formulation of drugs into tablets, which were feasible in the past, is no longer effective as drug molecules require more complex and advanced drug release techniques to handle insoluble compounds. There are various techniques to increase bioavailability, but making them feasible requires expertise and experience in how to apply them, so formulations are more likely to be used effectively. The use of solvents such as isopropanol, ethanol, and acetone is a practical way for developers to increase the solubility of most drugs. In addition, the solvent methods used to disperse drug substances can also be applied to poorly soluble compounds that are prevalent in today’s therapeutic compounds.
1.2 Drug Formulations That Require Innovative Processes To Advance Finished Products
As the rate of discovery of new drugs that improve existing therapeutics slows, innovative processes are required to advance finished drug formulations. Using innovative technologies can help improve therapeutic options and reduce the industry’s reliance on finding new active molecules. Continually employing various strategies that enhance drug absorption is critical for formulation scientists.
1.3 Application Of Target Product Profile (TPP)
Formulation formulators recommend an orthogonal approach and be open to a variety of approaches, especially in the early stages of development. Good development practice begins with the client providing a clear Target Product Profile (TPP), which describes the ideal drug product profile, including route of administration, dosage, form factor, pH, particle size distribution, etc. Once the physicochemical characteristics of TPPs and active substances are understood, it will be possible to develop potential drug release technologies that may enable TPPs.
1.4 Taking A Holistic Approach Is The Key To Success
And the key to success is to take a holistic approach that takes into account the overall requirements of any drug formulation; from the properties of the API (theoretically the only ingredient that cannot be ignored) to the end-use market, patient needs and target indications.
Part 2 Advantages Of The Accelerated Drug Approval Pathway
2.1 Accelerated Drug Approval Pathways Have Clear Benefits For Drug Development
Accelerated drug approval pathways can not only help shorten development time, but also significantly reduce costs. Taking the US FDA’s 505(b)(2) drug approval pathway as an example, innovative drug dosage forms are being realized thanks to the opportunities offered by the accelerated development pathway. The main advantage of this pathway is that 505(b)(2) drug approval pathway applicants can use clinical data provided by other companies to seek US FDA approval without having to perform all the work of a traditional new drug application. This pathway is being used to improve existing drug products, including new dosage forms, indications, dosing regimens and new routes of administration. Through accelerated drug approval pathways such as 505(b)(2), developers are finding ways to breathe new life into existing products in an economical way. According to the FDA, the pathway gives drug developers a faster path to improve existing drugs, including new formulations that work faster or combine two active ingredients in new ways. This includes creating new routes of administration to enhance therapeutic efficacy or dose compliance.
2.2 Past And Present Of US FDA505(b) (2) Drug Approval Pathway
In 1984, Congress passed the “Drug Price Competition and Patent Term Amendment” (Hatch-Waxman Amendment), and the revised section 505 of the Federal Food, Drug and Cosmetic Act provides three paths for new drug applications: (1) 505(b ) (1) : The application contains a complete safety and efficacy study report. (2) 505(b) (2): The application contains a complete safety and efficacy study report, but at least some of the information is derived from studies that were not conducted by the applicant or that the applicant has no right to cite. m(3) 505(j): The application contains information to prove that the proposed drug has exactly the same active ingredients, dosage form, strength, route of administration, label information, quality, characteristics and indications, etc. of the reference drug.
2.3 Drugs Eligible For 505(b)(2) Application
(1) Drugs with new indications: New use of old drugs is a method for pharmaceutical research units to reduce R&D costs and shorten clinical trial time. Using confirmed chemical molecules to conduct research on the effects of certain diseases can speed up the development of old drugs It can even become a new drug for rare diseases.
(2) Drugs with changed dosage forms, doses, prescriptions, dosing regimens or administration routes: The main direction of innovation in new preparations of drugs marketed abroad is preparation technology innovation, administration route innovation, innovation in reducing the number of oral administration, and packaging innovation .
(3) Prodrugs of existing drugs: In order to improve drug bioavailability, increase drug stability, reduce toxic and side effects, and promote long-acting drugs, many companies choose precursor development. Prodrugs are estimated to account for about 10% of the world’s pharmaceuticals. In addition to the above three points, new combination products and, in some cases, drugs containing new active ingredients are also suitable for 505(b) (2) application.
2.4 Challenges Of US FDA505(b) (2) Drug Approval Pathway
505(b)(2) can save the approval time to the greatest extent in the absence of priority review, accelerated approval, breakthrough designation, fast track approval. However, after the sponsor initiates the New Molecular Entity (NME) to enter the accelerated review process, due to the patent or exclusive protection of the reference drug, the active ingredient of the 505(b) (2) application has no patent, and at the same time, to ensure the validity of the application And safety, FDA needs additional research, at this time 505(b) (1) will be a better solution.
2.5 Regulatory Agencies In Other Countries Of The World Also Provide Options For Accelerated Drug Approval Pathways
Globally, other regulatory agencies also offer accelerated pathway options for drug approval, for example in Europe, the European Medicines Agency (EMA) allows developers to submit applications through a hybrid procedure, roughly equivalent to 505(b)(2). The allure of accelerated drug approval pathways is prompting drug innovators to rethink existing marketed drugs and reformulate them with a greater focus on patient-centricity. This has led to innovations such as long-acting injectables that require lower dosing regimens than before, or improved bioavailability of drugs so that they can be released by another, more convenient route of administration.
Part 3 Patient-Centered Approach To Drug Formulation Development Is Particularly Important
The patient or consumer must always be at the forefront of any development strategy. It should always be remembered that it is not the drug (ie API) that is administered to the patient, but the drug. For a formulation to achieve positive clinical outcomes and bring commercial success to the developer, patients must be willing to use it.
(1) A patient-centric approach to dosage forms is particularly important. Indeed, a patient-centred approach to dosage forms may be particularly important when considering specific patient populations. Traditional dosage forms, especially tablets, may not always be taken by patients as prescribed, which can lead to poor treatment outcomes and make a course of treatment significantly less effective. Pediatric and geriatric patients are particularly reluctant to swallow large pills, in which case powder or liquid formulations may provide more convenient treatment.
(2) Improving medication compliance in pediatric patients using modified-release formulations. Yet another way to improve patient experience and ultimately medication adherence in pediatric patients is through the use of modified-release formulations, as they have narrow therapeutic indices and can support dosage adherence strategies. Most patient groups respond well to taking medications that require fewer doses (and for longer periods of time) to be effective, with fewer side effects from dose fluctuations. In addition, fixed-dose combination products with multiple APIs and different modified-release profiles can provide more therapeutic value and better outcomes for pediatric and geriatric patients.
(3) Improving patients’ treatment compliance is achieved through taste masking. Another way to support patient-centric drug dosage forms is through taste masking. Overcoming this issue can also directly impact patient comfort with the product and improve treatment adherence.
(4) Improving the solubility and bioavailability of orally administered drugs can improve patient comfort. Adherence issues have also been identified in patient populations with chronic diseases. Treating chronic diseases with oral medicines can improve patient comfort and allow them to take their medicines at home. Another way to support patient-centric drug dosage forms is through taste masking. Overcoming this problem also directly impacts patient comfort with the product and improves treatment adherence.
(5) The principles of patient-centredness are being applied in drug development in a variety of ways. For example, genetic profiling and advanced analytics are aiding in personalized/precision medicine approaches by gaining insights into different patient populations as well as the pharmacokinetic and pharmacodynamic effects of drugs. Therefore, patients can be more selective in choosing medicines considering their efficacy in specific populations.
Part 4 The Importance Of Collaborating With Outsourced Partners For Formulation And Development
4.1 Importance Of Collaborating With Outsourced Partners For Formulation And Development For Unconventional Dosage Forms
Collaboration with an outsourced partner for formulation and development may be especially important for non-conventional dosage forms. Dosage forms (such as nasal and ophthalmic) as well as implantable devices and reservoirs may present additional complexities and regulatory issues for developers. Through outsourcing partners, developers can leverage expertise and technology that they do not have in-house. Another benefit: Outsourcing partners can also expand the resources available to developers. If a client has a backlog or lacks available resources, they can use an outsourcing partner as an extension of the in-house development team.
4.2 Flexibility Is Critical To The Success Of Drug Development
Flexibility and the ability to adapt to any changes that may occur during formulation development are critical to the success of drug development. By partnering with an organization with commercialization experience and technical expertise in complex dosage forms such as modified release or fixed dose combinations, companies will be able to overcome project challenges in an agile and efficient manner.
4.3 Specialization Is The Key To The Pharmaceutical Industry
If our customers are to invest in their own production facilities, they will have to invest significant resources and capital. Outsourcing allows drug developers to gain access to unique skills and support in the supply chain, which means that other benefits can be realized, such as faster time to market and lower costs in the long run.
Part 5 Areas That Will Grow In The Future
Previously neglected drug delivery routes such as nasal formulations will be developed in the near future. Nasal delivery can provide an ideal route and improve bioavailability for many drugs, especially those used to treat the central nervous system. This route of administration may also be applicable to unconventional drug substances such as biologics.
5.1 Increased Demand For Outsourcing Partners
The increasing popularity of high-potency ingredients being developed has led to an increased need for outsourcing partners who can effectively manage the associated control issues. Energy-efficient facilities are capital intensive and require strict controls. Therefore, it will be more economical for pharmaceutical companies to work with outsourcing partners to develop and manufacture products in a more efficient manner.
5.2 Demand Potential For Value-Added Improved Medicines In The Near Future
Another trend that will be important in the near future is value-added medicines based on well-known molecules with new uses, indications, finished dosage forms or strengths. These drugs are improvements on traditional generic drugs, which means higher costs, but they are more economical to develop than drugs based on new chemical entities.
5.3 Potential Trend Of Using Artificial Intelligence To Mine APIs
Currently, there is a trend in the world pharmaceutical industry to use artificial intelligence to mine APIs to reach relevant newly discovered biochemical pathways. The main trend in the future will be to integrate preparations with information technology and any related equipment, with a focus on making it simple and even attractive to patients to make it compliant. Ultimately, however, keeping the patient in mind will be critical when researching drug development. If patients do not like the dosage form, then they are less likely to take the drug, leading to poor treatment outcomes. Dosage forms should attract rather than repel the target population.