New formulation development is motivated by the desire to improve drug bioavailability.
To create a well-absorbed oral formulation for a poorly soluble drug, formulators need to understand both the physical and chemical properties of the active pharmaceutical ingredient (API) and must carefully control supplement excipients in an attempt to maximize bioavailability.
New API technologies are being developed to solve the problem of ensuring bioavailability, but other factors are becoming more important in driving innovation in formulation development.
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There is a growing demand from patients for medicines that are convenient to take and safe. As a result, the drug industry is inventing new types of tablets that combine several APIs. This trend for convenience has also led to new methods for modifying the release of existing medications using APIs.
Technological advances in the creation of excipients and advances in processing and manufacturing technologies are forcing formulators to change the way they conceive of new products. The need for safer and more consistent drug products is shaping their decisions. There comes the need for highly developed and customized technology like ours APM.
As regulatory agencies demand safer and more efficacious products, companies are focusing on the design of new formulations. If all want to know how to create a new formulation with our Acu Process Manufacturing Cloud Sofware. Schedule a DEMO
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Liquid drug formulations are used to begin first-in-human trials because they are faster and cheaper to develop, allow the dose to be varied, which is often required during Phase I clinical studies, and may maximize oral bioavailability. However, liquid drug formulations are rarely suited to commercialization due to their low stability, and later stage studies would be unable to take advantage of them. If a candidate continues to show promise during Phase I, there will be enough time to reformulate for later stage studies.
The strategy of focusing on early-stage formulations still holds, but opinions are growing that later-stage formulations should also be considered. This is because it allows for better informed do’s and don’ts no-go development decisions, which help pharmaceutical companies make most effective use of their R&D budgets. In addition, any useful stability and bioavailability data may save time later by helping to shape the development of formulations for later phase trials and commercialization.
Inhalers type of Products (pills, capsules, etc.)
Inhalation is a big business. Asthmatics and other people with respiratory diseases are willing to pay good money for effective inhaled drugs, because they hope it will deliver a faster onset of action and reduce their risk of side effects compared to oral remedies.
The formulation challenges are different for each kind of device used in inhalation delivery. With a metered dose inhaler, the droplet size is critical, as well as the viscosity of the solution. For a dry powder inhaler, particle engineering is required to achieve the right dispersion when inhaled.
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Developers of inhalable drugs face major challenges in creating safe and effective medications, even if the delivery device is used incorrectly.
The growing market for fixed dose combination products that contain two or more drugs is also prompting pharmaceutical companies to develop new formulations for their existing drugs. Physicians and patients are searching for ways to increase convenience and compliance by reducing the number of pills taken each day.
The challenge of combining two APIs in a single formulation is significant. In order to ensure that the respective ingredients are stable and behave appropriately from a pharmacokinetic and pharmacodynamics standpoint, the layering, palletization or Mini tabulation of these ingredients is vital.
Modified-release dosage forms
Demand for modified release drugs is also increasing the pace at which formulations are developed. While a number of factors can affect release patterns, drug release can be directed to the gut rather than the stomach to avoid drug degradation and gastric irritation. Consequently, the technology is very useful in developing new chemical entities (NCEs) as well as in life cycle management, packaging and repositioning of existing drugs.
Two factors drive demand for these products. First, sustained-release versions of medicines can reduce the number of pills or capsules that a patient takes and therefore reduce the risk that the patient will forget to take the medicine. These medicines can also cause lower peak plasma concentrations, which can result in fewer side effects.
Companies whose products face impending patent loss have modified release versions of the same product. Innovation in a new form of release helps to maintain market share.
The demand for technologies like Acu Process Manufacturing (APM) that can control the release of active pharmaceutical ingredients has led to an increase in multi-particulate formulations, mixtures consisting of pellets.
Deterrents to abuse
In response to concerns about prescription drug abuse, particularly involving opioids, regulators in the U.S., Europe and elsewhere advise pharmaceutical firms developing certain types of products to include technologies that will prevent them being abused.
In response to this recommendation, various technologies have been developed that prevent tablets from being crushed, melted or manipulated in such a way that the API is released. The most effective technology depends on the drug, as some stop pills from being dissolved in alcohol while others prevent them releasing their activities as a result of physical manipulation.
Pediatric medications formulations
It is important to know that children have different needs than adults do. They need smaller doses, are unable to swallow tablets or capsules and require the dosage form to be appropriate for use with a child’s body weight. In addition, liquid dosage forms are much easier to take than tablets or capsules and can be easily adjusted for age, body weight and changes in condition.
Despite the fact that liquid dosage forms are associated with several problems, such as unpleasant taste and poor stability, there are many advantages of using such dosage forms. Unpleasant taste is relatively easy to hide in a tablet or a capsule, but it cannot be so easily hidden in a liquid formulation. However, this problem can be mitigated by proper formulation of the liquid dosage form.
To ensure long shelf life, careful formulation development is needed. Dry syrups in bottles may improve shelf stability.
New formulations will need careful formulation, including tests for shelf life. This may also be improved using dry syrups, which are reconstituted prior to use.
Large molecules used to treat disease
The trend in the pharmaceutical industry from small molecule products to large molecule products synthesized in biological systems is spurring formulation development. Protein therapeutics, vaccines, etc. are injected into patients, but this method of delivery may change as the focus on large molecules increases.
Recently, there have been renewed efforts to develop oral large molecule drug formulations. Researchers are attempting to overcome the challenge of developing oral formulations for biologic drugs. They face significant technical issues in ensuring bioavailability from oral formulations.
Summary In Short
Innovation in the development of drug formulations will continue to be driven by efforts to improve drug bioavailability, but advances in processing and manufacturing technology and patient-centricity will lead to a more exciting future.
The rapid growth of emerging markets—economies where productivity is low—will drive further development of cost-effective drug formulations and delivery systems.
With the changes in industry, you have to consider technology that’s flexible for changes and affordable with the business size, uses and capacity. Our Acu Process Manufacturing fits best for these requirements. You can SCHEDULE OVERVIEW CALL.
Sangeetha brings 20 years of experience in Information Technology which includes Solution architecting, building micro services, research, and evaluation of business applications, integrating apps.