Medication Lubricants for Oral Delivery of Drugs: Oral Processing Reduces Thickness, Changes Characteristics, and Improves Dissolution Profile.

Swallowing oral solid dosage forms is challenging for those who have medication swallowing difficulties, including patients with dysphagia. One option is to mix the drug (whole or crushed) with a thick vehicle (medication lubricant). Previous in vitro studies consistently suggest that thick vehicles could impact the dissolution of solid dosage forms, potentially influencing their therapeutic effectiveness, but do not account for changes that happen during oral processing and swallowing. This study aims to investigate the potential impact of medication lubricants on drug release and examine the effect of oral processing. In vitro dissolution of whole and crushed paracetamol tablets mixed with five commercially available medication lubricants (two IDDSI level 2, two IDDSI level 3, and one IDDSI level 4) were tested with and without oral processing; a medication lubricant with/without paracetamol was placed in the mouth (five healthy volunteers), prepared for swallowing, but then expectorated and assessed for physical characteristics and drug release. Medication lubricants, both alone and mixed with crushed paracetamol tablets, showed a significant decrease in viscosity after oral processing. Without oral processing, IDDSI level 3 and 4 lubricants significantly delayed the dissolution of paracetamol tablets. After oral processing, particularly with crushed tablets, there was a substantial increase in the dissolution rate. These findings suggest that dissolution testing overestimates the impact of medication lubricants on drug dissolution. Therefore, using in vitro dissolution tests to predict the dissolution rate of medications mixed with thick vehicles is discouraged. It is essential to consider ways to incorporate the effects of the oral environment and oral processing on thick vehicles used for oral medication administration.

The prevalence and perceived effectiveness of using a medication-swallowing lubricant in aged care facilities across Australia.

Objective: To explore the extent of use and perceived effectiveness of using a medication lubricant that is specifically designed to help people who struggle to swallow their solid medications whole. Method: Health care workers of varying professional levels in aged care facilities (ACFs) across Australia who are involved in medication administration were invited to participate in a structured online survey. Results: Of the 355 health care workers who completed the survey, 48% had used the medication lubricant to aid administration of whole and/or crushed solid oral dosage forms, and of these 89% agreed with the statement that "it is effective method to facilitate medication swallowing in residents." The main benefits of using the medication lubricant were considered to be easier medication administration to residents (49%), reduction in need for crushing of medications (34%), and better adherence with medications (33%). Conclusions: This study showed that using a medication lubricant for aged care residents may facilitate the process of medication administration for health care workers, which they perceive to improve residents' adherence with medications. Serious complications associated with solid dosage form modification may also be decreased by using a medication lubricant, as the need for modifying medications is reduced. Therapeutic Goods Administration (TGA)-approved medication lubricants could therefore be a valuable tool to aid the medication administration for patients who have difficulties swallowing medications. Future research may consider the clinical efficacy and acceptability of medication lubricants specifically for people with swallowing difficulties.

A Difficult Pill to Swallow: An Investigation of the Factors Associated with Medication Swallowing Difficulties.

BACKGROUND: Many medications are available as solid oral dosage forms such as tablets and capsules; however, some people find these medications difficult to swallow. AIM: To identify whether certain psychological, oral sensory, and oral motor characteristics contribute to medication swallowing difficulties. METHODS: A sample of healthy adults from two academic institutions in Brisbane were assessed for their experiences with swallowing solid oral dosage forms, food preferences, and food neophobia. The gag reflex, oral cavity size, fungiform papillae count, and chewing efficacy were also evaluated followed by a capsule-swallowing task. Primary outcome was the incidence of medication swallowing difficulties. Secondary outcomes were the association of medication swallowing difficulties with psychological, oral sensory, and oral motor factors. RESULTS: Of 152 subjects, 32% reported difficulty swallowing tablets or capsules whole. This group was significantly more likely to have had a memory of choking on medications compared to those without medication swallowing difficulties (OR = 7.25, p < 0.05). Current medication swallowing difficulties were significantly associated with a smaller mouth cavity size (OR = 2.98, p < 0.05), a higher density of taste receptors on the tongue (OR = 3.27, p < 0.05), and were higher among those who chewed a jelly candy to non-homogenous particle size (OR = 4.1, p < 0.05). Current medication swallowing difficulties were associated with lower confidence in swallowing large capsules (000 size: OR = 0.47, 00 size: OR = 0.39, p < 0.05). No associations were found between medication swallowing difficulties and the gag reflex or food neophobia. CONCLUSION: A combination of heightened oral perception characterized by a small oral cavity and high taste sensitivity compounded by a past choking episode on medications may be precipitating factors for medication swallowing difficulties. These factors may be helpful in identifying individuals who are more likely to experience difficulty swallowing medications.

Factors that affect health-care workers' practices of medication administration to aged care residents with swallowing difficulties: An Australia-wide survey study.

OBJECTIVES: To understand the barriers and facilitators of medication administration to aged care residents with swallowing difficulties. METHODS: Health-care workers in aged care facilities across Australia involved in medication administration to residents completed an online survey. RESULTS: Of 355 respondents, 90.9% reported 'everyday' encounters with residents with swallowing difficulties and 94.1% modified medications to facilitate administration. Time constraints (63.4%) and workload (69.0%) were common barriers. Only 39.0% believed swallowing abilities are considered at the prescribing stage. Pill size (95.8%), polypharmacy (75.2%) and lack of alternative formulations (74.9%) contributed to these challenges. Support from other health-care professionals (91.5%) and training (85.9%) were the most favoured facilitators. CONCLUSION: Health-care workers are faced with various challenges when caring for residents with swallowing difficulties. Promoting multidisciplinary collaborations, provision of training and medication review services, and improving skill mix and staffing composition in aged care facilities are needed to address these challenges.

Are Medication Swallowing Lubricants Suitable for Use in Dysphagia? Consistency, Viscosity, Texture, and Application of the International Dysphagia Diet Standardization Initiative (IDDSI) Framework.

Medication lubricants are thick liquids or gels that are designed to aid swallowing of solid oral dosage forms. Tablets and capsules are placed within a spoonful of the product for swallowing. The aim of this study was to describe and compare commercially available medication lubricants in terms of textural suitability for patients with dysphagia. Twelve medication lubricants were characterised according to the International Dysphagia Diet Standardisation Initiative (IDDSI) framework. Apparent viscosity, yield stress, thickness consistency, and various texture features were compared. Gloup Forte was the only medication lubricant classified as IDDSI level 4 (pureed/extremely thick) at room (24 °C) temperature. Four other Gloup products were IDDSI level 3 (liquidised/moderately thick) at room temperature but testing at 4 °C or pouring from the container instead of using the pump dispenser resulted in classification as IDDSI level 4. The IDDSI Flow test would have classified MediSpend and Slo Tablets as IDDSI level 3, but their very low yield stress led to these fluids flowing too quickly through the prongs of a fork and so these were classified as <3. Severo was IDDSI level 2. Heyaxon and the two versions of Magic Jelly tested contained lumps, and Swallow Aid had exceptionally high viscosity, hardness, adhesiveness, and gumminess, classifying them as IDDSI Level 7 ("regular textures") and therefore as unsuitable for people with dysphagia according to IDDSI. This study provides valuable information to help with the selection of a safe medication lubricant with appropriate thickness level suited to each individual with dysphagia.

Factors affecting Australian aged care facility workers in administering oral medication to residents with swallowing difficulties.

Swallowing difficulties are common in older people and can complicate the administration of oral medications. The aim of this study was to explore factors affecting healthcare workers in their practices of oral medication administration to aged care residents with swallowing difficulties. A purposeful sample of 17 healthcare workers composed of clinical/care managers, registered nurses (RNs), enrolled nurses (ENs), and assistants in nursing (AINs) from three aged care facilities in Queensland, Australia participated in semi-structured interviews. Leximancer was used for quantitative content analysis. The responses centered on three main factors. Participants discussed workprocess-related factors including time, workload, and stress and frustrations resulting from work processes. Medication-related factors included strategies to facilitate medication administration, uncertainties around modifying medications, availability/cost of alternatives, multidisciplinary medication management, prescribing considerations, and polypharmacy. Resident-related factors were discussed around individualized needs of residents especially those with dementia-associated swallowing difficulties. Ideas differed among the four groups of participants. Managers discussed workprocess-related factors pertaining to staff and facility. RNs focused on how clinical aspects of the medication practices were affected by work processes. ENs were task-oriented and their responses focused on work processes. AIN responses centered on reliance on RNs in performing medication tasks. The findings suggest that healthcare workers' practices of medication administration to residents with swallowing difficulties are affected by various factors associated with work processes, medications, and resident characteristics. Although these factors affect all levels of healthcare workers, the needs of each group vary depending on their level of training and responsibilities.

Appropriateness of oral dosage form modification for aged care residents: a video-recorded observational study.

Background Dosage forms of oral medications are frequently modified in aged care facilities by crushing/splitting tablets or opening capsules to facilitate medication administration for residents with swallowing difficulties. These practices pose safety concerns including the risk of adverse events resulting from loss of dose during transfer and alteration in the rate of absorption. Objective To identify the incidence, methods, and appropriateness of oral dosage form modification practices in aged care facilities. Setting A purposive sample of four urban and regional aged care facilities in Queensland, Australia. Method The processes of modification of oral dosage forms were observed and video-recorded using an action camera placed on medication trolleys. Each video was then reviewed and the details of the medication modification processes were recorded in a data collection form. The appropriateness of the practices of dosage form modification was evaluated against existing national guideline (Australian Don't Rush to Crush Handbook). Deviations from the instructions in the guideline were considered as inappropriate practice. Main outcome measure Incidence and characteristics of inappropriate modification of oral dosage forms. Results Oral dosage forms were modified in 25.7% of 810 observed medications. The most common methods of dosage form modification included crushing tablets with a manual crushing device (71.6%), cutting/splitting tablets (20.2%), and opening capsules (4.3%). According to the national guideline, 12.5% of the modification instances were inappropriate. Inappropriate practices were commonly associated with the suboptimal methods of medication preparation where medications were unsuitably modified, mixed, spilled, or incompletely dosed. Conclusion The modification of oral dosage forms seems a common practice in aged care facilities in Queensland. However, some of these modifications do not comply with the requirements of good practice according to existing guidelines. Healthcare workers in aged care facilities need to be supported and upskilled with effective training to promote the best and safest practices of ODF modification.

Evaluating chewing function: Expanding the dysphagia field using food oral processing and the IDDSI framework.

The dysphagia field is still in relative infancy with a sophisticated knowledge base amassed since the early 1980's. The desire to identify aspiration and prevent life threatening pneumonia has resulted in a focus on the complexities of swallowing liquids. However, humans also ingest saliva, food, and oral medications, with the potential for these substances to incompletely clear the pharynx, be aspirated or block the airway. Safe swallowing of solid food in particular requires adequate chewing function, good oral control, and sufficient higher cortical function. Although screening and assessment for liquid swallowing safety is well established, the same cannot be said for the evaluation of safety to chew and swallow different food textures. While research into liquid swallowing physiology and its clinical application has largely come from the medical and allied health fields, our knowledge of chewing function for food textures comes from food texture research and food sensory science arenas. There is an exciting opportunity to bring the medical and food texture science fields together to expand our knowledge base on human chewing function, with clinical application to people with dysphagia. The development of the IDDSI Framework as an international standardized way of describing and labelling food texture and drink thickness allows the field to move toward management of texture modified food and thick liquids in a coordinated fashion, speaking the same language. This commentary will describe what we know of chewing function and how it is assessed clinically, proposing methods of assessment that utilize the IDDSI Framework.

Dosage form modification and oral drug delivery in older people.

Many people cannot swallow whole tablets and capsules. The cause ranges from difficulties overriding the natural instinct to chew solids/foodstuff before swallowing, to a complex disorder of swallowing function affecting the ability to manage all food and fluid intake. Older people can experience swallowing difficulties because of co-morbidities, age-related physiological changes, and polypharmacy. To make medicines easier to swallow, many people will modify the medication dosage form e.g. split or crush tablets, and open capsules. Some of the challenges associated with administering medicines to older people, and issues with dosage form modification will be reviewed. Novel dosage forms in development are promising and may help overcome some of the issues. However, until these are more readily available, effective interdisciplinary teams, and improving patient health literacy will help reduce the risk of medication misadventures in older people.

Nurse experiences of medication administration to people with swallowing difficulties living in aged care facilities: a systematic review of qualitative evidence.

OBJECTIVE: To identify nurses' experiences of administering oral medications to residents of aged care facilities (ACFs) with swallowing difficulties. INTRODUCTION: Administering medicines to older people with swallowing difficulties is a challenging task. Nurses frequently modify oral medications e.g. by crushing/splitting tablets or opening capsules, to facilitate the administration process. These practices are associated with an increased risk of medication administration errors. However, the reasons for these practices from the nurse's perspective are not well understood. INCLUSION CRITERIA: The review investigated studies on the experiences of nurses of any level with the responsibility of medication administration in ACFs in terms of problems and challenges they encountered when administering oral medicines to aged care residents with swallowing difficulties. Aged care facilities providing all levels of care were considered for inclusion. Qualitative studies including, but not limited to, phenomenology, grounded theory, ethnography and action research designs as well as mixed methods studies and text and opinion papers were considered. METHODS: A comprehensive database search of PubMed, CINAHL, Embase and Scopus was conducted between October and December 2016. MedNar and ProQuest Dissertations and Theses were used to search for gray literature. No date limitation was applied. The Joanna Briggs Institute Qualitative Assessment and Review Instrument critical appraisal tool (JBI-QARI) was used to assess the quality of the papers. The JBI-QARI data extraction instrument was used to extract qualitative findings. Data synthesis was not applicable in the final analysis due to the inclusion of only one article. RESULTS: The initial search resulted in 1681 unique titles for screening. A total of 202 abstracts were screened, after which a full-text review conducted for 19 articles. After the full-text review, only one article was eligible to be included in the final report. The included study scored highly in terms of methodological quality. The findings highlighted issues around time constraints, complexity of medication administration process to residents of ACFs with swallowing difficulties, cost and resources for alternative strategies, inefficient information flow and communication among healthcare professionals, and nurses' knowledge and training needs. CONCLUSION: The limited findings of this systematic review indicate that further research is necessary to provide evidence of nurses' experiences with regards to administering oral medications to older people with swallowing difficulties living in ACFs. A comprehensive understanding of these experiences may lead to organizational system changes to support nurses and older people with swallowing difficulties in ACFs.

Age-Related Changes to Eating and Swallowing Impact Frailty: Aspiration, Choking Risk, Modified Food Texture and Autonomy of Choice.

Reductions in muscle mass and strength are well known complications of advancing age. All muscles of the body are affected, including those critical to chewing and swallowing. A diagnosis of frailty and its features of weakness and unintentional weight loss are particularly relevant to the aging swallowing system. Age related changes to eating and swallowing function means that there is a natural tendency for elders to self-select 'soft' foods due to loss of dentition and fatigue on chewing. However, it is not well known that tooth loss and poor dental status is associated with increased choking risk, especially as people age. In fact, people over 65 years of age have seven times higher risk for choking on food than children aged 1-4 years of age. Texture modified foods are provided clinically to reduce choking risk and manage dysphagia. Although certain food textures offer greater swallowing safety, they significantly restrict food choice. This commentary paper will highlight age-related changes to the eating and swallowing system, noting especially those that are relevant for frail elders. Swallowing impairments also affect the ability to manage liquids, and aspiration risk in healthy and frail elders is also discussed. Modified food textures that are most often recommended by clinicians to maintain sufficient oral intake and reduce choking risk will be described, while also highlighting the nutritional challenges associated with these foods and offering some solutions. The ethical challenges associated with balancing the autonomy of choice of food textures with swallowing safety will be addressed.

Unlocking opportunities in food design for infants, children, and the elderly: Understanding milestones in chewing and swallowing across the lifespan for new innovations.

Intake of a variety of foods increases the likelihood of good general health. From as early as life in utero, humans are exposed to flavor. Further flavor imprinting occurs via breast milk, increasing the likelihood of acceptance of a variety flavors when solids are introduced. While first foods need to be smooth and runny, experience managing soft lumps is required for rudimentary development of chewing skills. Texture experiences are critical to providing building blocks for food acceptance and gradual increase in the range of food textures eaten. Persistence in offering flavors and textures on multiple occasions increases the likelihood of acceptance of new foods. Opportunities exist in novel food texture use and flavor bridging to improve food variety in children. During adulthood lifestyle changes impact on chewing and gastrointestinal efficiency affecting the variety of food consumed. Foods that are moist, and encourage the consumer to slow down and savor food may reduce diseases affecting the esophagus. The aging process sees an increase in medication use with an impact on reduction in saliva flow. Further, physiologic changes in taste and olfaction that occur with aging may see elders benefit from novel food design that utilizes the intact trigeminal system. New food design opportunities exist in the areas of carbonation, dissolvable solids, microencapsulation of flavor volatiles or pressurized carbon dioxide granules. The use of standardized nomenclature for food labeling, description, and measurement methods such as that used by the International Dysphagia Diet Standardisation Initiative is advocated to accelerate food oral processing research. PRACTICAL APPLICATION: The human feeding, chewing, and swallowing mechanism adapts and changes over the life span. There are opportunities to influence flavor development from as early as life in utero, and through milk feeds. Infants also need exposure to soft lumps to develop rudimentary chewing skills that lay the foundation for mature chewing. Melt-in-the-mouth textures and familiar flavors can help children to bridge to new food and diminish development of picky eating. Similar textures can also be used for the elderly particularly if used with food flavors and compounds that excite the trigeminal system to promote increased food variety. Adults taking medication with dry mouth side effects benefit from moist foods. Special populations, such as those with swallowing difficulties, may benefit from use of micro encapsulated compounds that trigger the trigeminal pathway. Introduction of a food texture labeling system is advocated.

Nurses' experiences of medication administration to people with swallowing difficulties in aged care facilities: a systematic review protocol.

REVIEW QUESTION/OBJECTIVE: The objective of this review is to identify the experiences of nurses in administering oral medications to residents of aged care facilities with swallowing difficulties.More specifically, the review question is:What problems do nurses experience when administering oral medicines to people with swallowing difficulties living in aged care facilities?

Development of International Terminology and Definitions for Texture-Modified Foods and Thickened Fluids Used in Dysphagia Management: The IDDSI Framework.

Dysphagia is estimated to affect ~8% of the world's population (~590 million people). Texture-modified foods and thickened drinks are commonly used to reduce the risks of choking and aspiration. The International Dysphagia Diet Standardisation Initiative (IDDSI) was founded with the goal of developing globally standardized terminology and definitions for texture-modified foods and liquids applicable to individuals with dysphagia of all ages, in all care settings, and all cultures. A multi-professional volunteer committee developed a dysphagia diet framework through systematic review and stakeholder consultation. First, a survey of existing national terminologies and current practice was conducted, receiving 2050 responses from 33 countries. Respondents included individuals with dysphagia; their caregivers; organizations supporting individuals with dysphagia; healthcare professionals; food service providers; researchers; and industry. The results revealed common use of 3-4 levels of food texture (54 different names) and ≥3 levels of liquid thickness (27 different names). Substantial support was expressed for international standardization. Next, a systematic review regarding the impact of food texture and liquid consistency on swallowing was completed. A meeting was then convened to review data from previous phases, and develop a draft framework. A further international stakeholder survey sought feedback to guide framework refinement; 3190 responses were received from 57 countries. The IDDSI Framework (released in November, 2015) involves a continuum of 8 levels (0-7) identified by numbers, text labels, color codes, definitions, and measurement methods. The IDDSI Framework is recommended for implementation throughout the world.

Oral medication delivery in impaired swallowing: thickening liquid medications for safe swallowing alters dissolution characteristics.

Acetaminophen (paracetamol) is available in a wide range of oral formulations designed to meet the needs of the population across the age-spectrum, but for people with impaired swallowing, i.e. dysphagia, both solid and liquid medications can be difficult to swallow without modification. The effect of a commercial polysaccharide thickener, designed to be added to fluids to promote safe swallowing by dysphagic patients, on rheology and acetaminophen dissolution was tested using crushed immediate-release tablets in water, effervescent tablets in water, elixir and suspension. The inclusion of the thickener, comprised of xanthan gum and maltodextrin, had a considerable impact on dissolution; acetaminophen release from modified medications reached 12-50% in 30 min, which did not reflect the pharmacopeia specification for immediate release preparations. Flow curves reflect the high zero-shear viscosity and the apparent yield stress of the thickened products. The weak gel nature, in combination with high G' values compared to G'' (viscoelasticity) and high apparent yield stress, impact drug release. The restriction on drug release from these formulations is not influenced by the theoretical state of the drug (dissolved or dispersed), and the approach typically used in clinical practice (mixing crushed tablets into pre-prepared thickened fluid) cannot be improved by altering the order of incorporation or mixing method.

"A Day in the Life of the Fluid Bolus": An Introduction to Fluid Mechanics of the Oropharyngeal Phase of Swallowing with Particular Focus on Dysphagia.

By following the path of a liquid bolus, from the oral preparatory phase to the esophagus, we show that a few fundamental concepts of fluid mechanics can be used to better understand and assess the importance of bolus viscosity during human swallowing, especially when considering dysfunctional swallowing (dysphagia) and how it can be mitigated. In particular, we highlight the important distinction between different flow regimes (i.e. viscosity controlled versus. inertia controlled flow). We also illustrate the difference between understanding bolus movements controlled by a constant force (or pressure) and those controlled by a constant displacement (or velocity). We limit our discussion to simple, Newtonian liquids where the viscosity does not depend on the speed of flow. Consideration of non-Newtonian effects (such as shear thinning or viscoelasticity), which we believe play an important part in human swallowing, requires a sound grasp of the fundamentals discussed here and warrants further consideration in its own right.

Erratum to: The Influence of Food Texture and Liquid Consistency Modification on Swallowing Physiology and Function: A Systematic Review.

Erratum to: Dysphagia DOI 10.1007/s00455-014-9578-x. In the original version of this article, Fig. 1 was published incorrectly. The corrected figure is given below.

The influence of food texture and liquid consistency modification on swallowing physiology and function: a systematic review.

Texture modification has become one of the most common forms of intervention for dysphagia, and is widely considered important for promoting safe and efficient swallowing. However, to date, there is no single convention with respect to the terminology used to describe levels of liquid thickening or food texture modification for clinical use. As a first step toward building a common taxonomy, a systematic review was undertaken to identify empirical evidence describing the impact of liquid consistency and food texture on swallowing behavior. A multi-engine search yielded 10,147 non-duplicate articles, which were screened for relevance. A team of ten international researchers collaborated to conduct full-text reviews for 488 of these articles, which met the study inclusion criteria. Of these, 36 articles were found to contain specific information comparing oral processing or swallowing behaviors for at least two liquid consistencies or food textures. Qualitative synthesis revealed two key trends with respect to the impact of thickening liquids on swallowing: thicker liquids reduce the risk of penetration-aspiration, but also increase the risk of post-swallow residue in the pharynx. The literature was insufficient to support the delineation of specific viscosity boundaries or other quantifiable material properties related to these clinical outcomes. With respect to food texture, the literature pointed to properties of hardness, cohesiveness, and slipperiness as being relevant both for physiological behaviors and bolus flow patterns. The literature suggests a need to classify food and fluid behavior in the context of the physiological processes involved in oral transport and flow initiation.