Patient-centric drug product development: Acceptability across patient populations - Science and evidence.

The 6th APV (Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnologie e.V., The International Association for Pharmaceutical Technology) Winter Conference took place in Salzburg (Austria) from January 19-20, 2023.

Patient engagement in pharmaceutical development: Where are we? - Report from a symposium.

In recent years, the term "patient engagement" has found its way into healthcare and specifically into the field of drug development. To better understand the actual status of "patient engagement" in drug development, a symposium was organized by the Drug Research Academy of the University of Copenhagen (Denmark) on November 16, 2022. The symposium brought together experts from regulatory authorities, industry, academia and patients to share their views and experience of and with patient engagement in drug product development.

Trends in oral small-molecule drug discovery and product development based on product launches before and after the Rule of Five.

In 1997, the 'Rule of Five' (Ro5) suggested physicochemical limitations for orally administered drugs, based on the analysis of chemical libraries from the early 1990s. In this review, we report on the trends in oral drug product development by analyzing products launched between 1994 and 1997 and between 2013 and 2019. Our analysis confirmed that most new oral drugs are within the Ro5 descriptors; however, the number of new drug products of drugs with molecular weight (MW) and calculated partition coefficient (clogP) beyond the Ro5 has slightly increased.

Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes - A proposed roadmap.

The increasing awareness of acceptability and usability of pharmaceutical drug products by the patient as a key quality requirement continues to drive need for integrating patient centric drug product design into the pharmaceutical development process. The complex matrix of multiple drug product related decisions during the early drug development process often limits patient-centric drug product (PCDP) design options in the final commercial drug product development phase. To integrate the specific needs and perspectives of patients into drug development and product design process, a rational approach integrated into the complex development matrix is required from the start and weighs product development decision options accordingly.

Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population.

Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation.

Focusing on powder processing in dry powder inhalation product development, manufacturing and performance.

Dry powder inhalers (DPI) are well established products for the delivery of actives via the pulmonary route. Various DPI products are marketed or developed for the treatment of local lung diseases such as chronic obstructive pulmonary disease (COPD), asthma or cystic fibrosis as well as systemic diseases targeted through inhaled delivery (i.e.

A Quality by Design Framework for Capsule-Based Dry Powder Inhalers.

Capsule-based dry powder inhalers (cDPIs) are widely utilized in the delivery of pharmaceutical powders to the lungs. In these systems, the fundamental nature of the interactions between the drug/formulation powder, the capsules, the inhaler device, and the patient must be fully elucidated in order to develop robust manufacturing procedures and provide reproducible lung deposition of the drug payload. Though many commercially available DPIs utilize a capsule-based dose metering system, an in-depth analysis of the critical factors associated with the use of the capsule component has not yet been performed.

Barriers and potential solutions in the recruitment and retention of older patients in clinical trials-lessons learned from six large multicentre randomized controlled trials.

Background: older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients.

Objective: to identify key barriers and to discuss solutions to specific issues affecting recruitment and retention of older participants in clinical trials based on experience gained from six current European randomised controlled trials (RCTs) focusing on older people.

Methods: a multidisciplinary group of experts including representatives of the six RCTs held two networking conferences and compiled lists of potential barriers and solutions.

An Investigation into the Relationship between Xanthan Gum Film Coating Materials and Predicted Oro-Esophageal Gliding Performance for Solid Oral Dosage Forms.

Oral drug therapy is generally provided in the form of solid oral dosage forms (SODF) that have to be swallowed and move throughout the oro-esophageal system. Previous studies have provided evidence that the oro-esophageal transit of SODF depends on their shape, size, density, and surface characteristics. To estimate the impact of SODF surface coatings during esophageal transit, an in vitro system was implemented to investigate the gliding performance across an artificial mucous layer.

Better Medicines for Older Patients: Considerations between Patient Characteristics and Solid Oral Dosage Form Designs to Improve Swallowing Experience.

Oral drug administration provided as solid oral dosage forms (SODF) remains the major route of drug therapy in primary and secondary care. There is clear evidence for a growing number of clinically relevant swallowing issues (e.g.

Challenges and opportunities to include patient-centric product design in industrial medicines development to improve therapeutic goals.

In the past, drug developers in industry chose approaches mainly focusing on the drug product's efficacy, safety and quality according to the level required by regulatory expectations stipulated in guidelines, pharmacopoeia and other regulatory provisions. By putting more focus on the patient perspective, regulatory authorities are currently raising their requirements regarding successful product submissions. The increasing involvement of patients in the product development process (e.

Age-Related Medicine.

A meeting organised by the Academy of Pharmaceutical Sciences focussed on the challenges of developing medicines for older adults. International experts discussed the complexity introduced by polypharmacy and multiple morbidities and how the risk⁻benefit ratio of a medicine changes as an individual ages. The way in which regulatory authorities are encouraging the development of age-appropriate medicines was highlighted.

Patient behaviour in medication management: Findings from a patient usability study that may impact clinical outcomes.

Aims: Adequate medication management is a key condition to ensuring effective pharmacotherapy. However, it is well acknowledged that older people may encounter difficulties self-administering medicines in a correct manner.

Methods: A mixed method pilot study was performed to investigate medication self-management in older and multimorbid patients with polypharmacy.

An evaluation of the gliding performance of solid oral dosage form film coatings using an artificial mucous layer.

Oral drug delivery technology is mainly provided in the form of solid oral dosage forms (SODF) that have to be swallowed intact and move throughout the oro-esophageal system to release the drug content in the stomach or intestine. As there is growing evidence for an increasing prevalence of impaired swallowing functions in certain diseases, multimorbidity and advanced age, predictive in vitro methods for the oro-esophageal gliding behavior of SODF would be very useful. The gliding performance of different SODF polymer films was investigated across an artificial mucous layer using a versatile in vitro gliding system.

Patient centric drug product design in modern drug delivery as an opportunity to increase safety and effectiveness.

Introduction: The advances in drug delivery technologies have enabled pharmaceutical scientists to deliver a drug through various administration routes and optimize the drug release and absorption. The wide range of drug delivery systems and dosage forms represent a toolbox of technology for the development of pharmaceutical drug products but might also be a source of medication errors and nonadherence. Patient centric drug product development is being suggested as an important factor to increase therapeutic outcomes.

Polymer adhesion predictions for oral dosage forms to enhance drug administration safety. Part 2: In vitro approach using mechanical force methods.

Predicting the potential for unintended adhesion of solid oral dosage forms (SODF) to mucosal tissue is an important aspect that should be considered during drug product development. Previous investigations into low strength mucoadhesion based on particle interactions methods provided evidence that rheological measurements could be used to obtain valid predictions for the development of SODF coatings that can be safely swallowed. The aim of this second work was to estimate the low mucoadhesive strength properties of different polymers using in vitro methods based on mechanical forces and to identify which methods are more precise when measuring reduced mucoadhesion.

Polymer adhesion predictions for oral dosage forms to enhance drug administration safety. Part 3: Review of in vitro and in vivo methods used to predict esophageal adhesion and transit time.

The oral cavity is frequently used to administer pharmaceutical drug products. This route of administration is seen as the most accessible for the majority of patients and supports an independent therapy management. For current oral dosage forms under development, the prediction of their unintended mucoadhesive properties and esophageal transit profiles would contribute for future administration safety, as concerns regarding unintended adhesion of solid oral dosage forms (SODF) during oro-esophageal transit still remain.

Polymer adhesion predictions for oral dosage forms to enhance drug administration safety. Part 1: In vitro approach using particle interaction methods.

Solid oral dosage forms (SODF) are drug vehicles commonly prescribed by physicists in primary and secondary cares, as they are the most convenient for the patient and facilitate therapy management. Concerns regarding unintended adhesion of SODF during oro-esophageal transit remain, especially in multimorbid patients, bedridden patients and patients suffering from dysphagia. Hence, this factor should be considered during the development of SODF, and more attention should be given on the design of appropriate surface conditions considering patients with swallowing problems.

Orodispersible films: Towards drug delivery in special populations.

Orodispersible films (ODF) hold promise as a novel delivery method, with the potential to deliver tailored therapies to different patient populations. This article reviews the current strides of ODF technology and some of its unmet quality and manufacturing aspects. A topic highlights opportunities and limitations of inkjet printed ODF as a population-specific drug delivery.

Patients' appropriateness, acceptability, usability and preferences for pharmaceutical preparations: Results from a literature review on clinical evidence.

Patients play an important role in achieving the desired therapeutic outcomes, as they are frequently responsible for their own medication management. To facilitate drug administration and overcome medication issues, the patients' needs and preferences should be considered in the pharmaceutical drug product design. With the aim to evaluate the current state of evidence for patient appropriateness, acceptability, usability and preference for aspects of this design, a literature search was performed.

Identification of different shapes, colors and sizes of standard oral dosage forms in diabetes type 2 patients-A pilot study.

The clear identification of drug products by the patients is essential for a safe and effective medication management. In order to understand the impact of shape, size and color on medication identification a study was performed in subjects with type 2 diabetes mellitus (T2D). Ten model drugs differentiated by shape, size and color were evaluated using a mixed method of medication schedule preparation by the participants followed by a semi-structured interview.

Defining Patient Centric Pharmaceutical Drug Product Design.

The term "patient centered," "patient centric," or "patient centricity" is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient's quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that the pharmaceutical drug product design is also adequately addressing the particular patient's needs, i.