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Journal ArticleDOI

Acceptability of oral solid medicines in older adults with and without dysphagia: A nested pilot validation questionnaire based observational study

TL;DR: Assessment of acceptability of oral solid medicines in older ambulatory patients with and without dysphagia found that higher acceptability scores were seen in the dysphagic population than in the non-dysphagic population for all of the dosage forms that were easier to swallow than tablets and capsules.
About: This article is published in International Journal of Pharmaceutics.The article was published on 2016-10-30 and is currently open access. It has received 71 citations till now. The article focuses on the topics: Dysphagia & Population.

Summary (2 min read)

1. Introduction

  • Previous knowledge on these effects has been demonstrated in healthy young subjects; however, this remains unclear in older people especially those with existing swallowing difficulties.
  • The type of formulation might be another factor affecting the ability and willingness of older patients to take their medicines.
  • A number of solid oral dosage forms that are "easier to swallow" than tablets and capsules have been made available in recent years including orally disintegrating tablets (ODTs), dispersible tablets, mini-tablets and multi-particulates .
  • For older patients who cannot swallow tablets, the availability of these formulations could be beneficial.

2.2 Administration of the Sydney Swallow Questionnaire (SSQ)

  • The SSQ is a validated questinnarie and composed of 17 questions assessing oral and pharyngeal swallowing function with responses entered onto a 101 mm visual analog scale except for question 12 (R. C. Dwivedi et al., 2010; K. L. Wallace et al., 2000) .
  • The SSQ was administered to the participants during an interview which took place in the private consultation room in the pharmacy.
  • The participant placed a mark on the horizontal line of the visual analog scale.
  • The first millimeter of the line was disregarded and a score of 0-100 was calculated by measuring the distance from the center of the mark to the first millimeter of the line for each question.
  • The maximum possible total score for the SSQ was 1700, with higher score indicating greater severity of swallowing dysfunction.

2.3 Pilot of the Medicines Acceptability Questionnaire (MAQ)

  • The content/face validity of the MAQ was assessed by two experts in the field acting as respondents.
  • Cronbach's alpha test was conducted to evaluate the level of reliability and internal consistency using the Statistical Package of the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY, USA).
  • Cronbach's alpha scores of 0.7 or above were deemed as acceptable according to Nunnally and Bernstein (J. Nunnally and L. Bernstein, 1994) .
  • The MAQ was administered to the participants during the interview together with the SSQ.
  • The interviews were conducted by two of the authors (AG and JB).

2.4 Data analysis

  • Data analysis was performed using the Statistical Package of the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY, USA).
  • The results are reported as mean ± standard deviation (SD).
  • Spearman's nonparametric correlation was used to identify the presence of significant correlations between total SSQ score and age of participants or number of solid oral medicines taken daily.
  • The Mann-Whitney U test was conducted to assess links between gender of participants and total SSQ score, and comparing the means of participants' selfperceived health status between the dysphagia and non-dysphagia group.
  • Chi-Square test was conducted to evaluate the relationship between dysphagic status of the participant and difficulty in swallowing tablets and capsules.

3.1 Validation of the Medicines Acceptability Questionnaire (MAQ)

  • 3 Ability to swallow tablets and capsules in patients with and without dysphagia by the MAQ A total of 12 (7.8%) participants experienced ongoing difficulties in swallowing tablets and capsules according to the results from the MAQ.
  • Figure 1 shows percentage of participants who has chosen the size and shape of tablets that were perceived as starting to cause difficulty in swallowing.
  • The majority of participants with dysphagia found that tablets of sizes 11 mm and 13 mm might started to cause difficulties in swallowing; the percentages of participants selecting 11 mm or 13 mm were 52.9%, 52.9%, 58.8% and 64.7% for flat round, arched round, oblong and oval tablets respectively.
  • Similar results were observed regarding difficulties in swallowing capsules of different sizes in participants with and without dysphagia .
  • In participants with dysphagia, over a third (35%) selected size #00 as that which started to cause problems in swallowing; however, around 30% of these participants also considered size #2 to be difficult to swallow.

3.4 Acceptability of alternative solid oral dosage forms

  • A low proportion of participants had had experience of using the alternative solid oral dosage forms, except for dispersible/effervescent tablets which were referenced mainly to soluble paracetamol and dispersible aspirin tablets as examples (Table 3 ).
  • The acceptability scores of different oral solid dosage forms are shown in Figure 3 .
  • Participants described the good/bad points they considered for each formulation as listed in Table 4 .

4. Discussion

  • A range of medicine formulations have been made available for patients who find it difficult to swallow tablets and capsules.
  • The acceptability of these formulations in targeted patient groups is often unclear.
  • Studies have reported that increasing age is associated with increased severity and prevalence of dysphagia in elderly populations (G. Holland et al., 2011; K. Kawashima et al., 2004) .
  • Szcaesniak et al. studied SSQ score in a non-dysphagic population and found that there was no significant correlation between age and SSQ score (M. M. Szczesniak et al., 2014) .

5. Conclusions

  • A significant proportion of older patients attending community pharmacies have symptoms compatible with dysphagia.
  • These patients are more likely to have difficulties in swallowing tablets and capsules compared to those with no dysphagia.
  • Healthcare professionals should identify patients with high risk of having problems swallowing their medicines and assist in selecting most appropriate medicine dosage forms.
  • The development and availability of alternative oral formulations other than conventional tablets and capsules will likely to assist in medication administration and management in patient with dysphagia and might lead to better adherence.

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Citations
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Cites background from "Acceptability of oral solid medicin..."

  • ...Ease of swallowing Beyond the technical aspect of pharmaceutics, in terms of user experience, current oral solid dosage forms can also be difficult to swallow, especially for special populations including the geriatrics [65] and paediatrics [66]....

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  • ...In relation to orally administered dosage forms, the effect of palatability and size of the drug product on patient acceptability have been studied in recent years (Liu et al., 2016; Mittal, 2017)....

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TL;DR: This review provides a comprehensive and up-to-date analysis of oral dosage forms considering key aspects of formulation design including dosage considerations, ease of use, tolerability and safety, manufacturing complexity, stability, supply and cost.

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TL;DR: Packaging, orodispersible formulations, fixed dose combinations products, multiparticulate formulations, topical formulations and 3D printing are of particular relevance in a PCDPD process and will be addressed in this review.
Abstract: Medication adherence is a growing concern for public health and poor adherence to therapy has been associated with poor health outcomes and higher costs for patients. Interventions for improving adherence need to consider the characteristics of the individual therapeutic regimens according to the needs of the patients. In particular, geriatric and paediatric populations as well as dermatological patients have special needs/preferences that should be considered when designing drug products. Patient Centric Drug Product Pharmaceutical Design (PCDPD) offers the opportunity to meet the needs and preferences of patients. Packaging, orodispersible formulations, fixed dose combinations products, multiparticulate formulations, topical formulations and 3D printing are of particular relevance in a PCDPD process. These will be addressed in this review as well as their impact on medication adherence.

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  • ...Indeed, the patient’s adherence is generally improved with respect to conventional solid dosage forms [92,98]....

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References
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Journal ArticleDOI
TL;DR: Olanzapine orally disintegrating tablets may benefit acutely ill, non-compliant schizophrenic patients by facilitating acceptance of active antipsychotic drug therapy.
Abstract: The objective of this study was to determine if the orally disintegrating tablet formulation of olanzapine, Zyprexa Zydis, would facilitate antipsychotic medication compliance in acutely ill, non-compliant patients. Eighty-five acutely ill patients with schizophrenia or schizoaffective disorder who met medication non-compliance criteria received open-label olanzapine orally disintegrating tablets (1020 mgd) for up to 6 wk. Improvement in medication compliance was assessed using various rating scales to measure changes in psychopathology, medication-taking and compliance attitudes, and nursing care burden. Safety variables were also measured. Significant improvement from baseline was demonstrated in the Positive and Negative Syndrome Scale total score at Week 1 and subsequently (p0.001). Significant improvement from baseline was also seen in various scales measuring medication compliance, attitude, and nursing care burden (p0.05). Olanzapine orally disintegrating tablets were well-tolerated. Olanzapine orally disintegrating tablets may benefit acutely ill, non-compliant schizophrenic patients by facilitating acceptance of active antipsychotic drug therapy.

70 citations


"Acceptability of oral solid medicin..." refers methods in this paper

  • ...The use of ODTs in older patients has been documented, especially in patients with Parkinson’s and Alzheimer’s diseases, and patients under antipsychotic treatments who might be purposely non-adherent (V. Danileviciute et al., 2009; B. J. Kinon et al., 2003; P. A. Nausieda, 2005)....

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Journal ArticleDOI
TL;DR: It is concluded that different drug formulations can have significant effects on oesophageal transit, and hence on the development of drug induced oesphageal ulceration.
Abstract: The oesophageal transit of barium sulphate in small or large, heavy or light capsules or film coated and plain oval tablets was measured during fluoroscopy in five separate studies involving 175 subjects. Transit of large, but not small capsules was significantly faster than plain oval tablets in both erect and supine subjects (P less than 0.05). Heavy large capsules entered the stomach in all subjects within 20 s, whereas in all other studies some subjects retained dosage forms in the oesophagus for over 5 min. The transit of heavy capsules was significantly faster than light capsules in erect subjects (P less than 0.0005). Light capsules tended to have faster transit times than heavy capsules in the supine position. Film coating significantly enhanced oval tablet transit in erect (P less than 0.00003) and supine subjects (P less than 0.05). When large capsules of equal weight but less dense than film coated oval tablets were directly compared, the tablet transit was significantly superior in the erect subjects (P less than 0.0001). In supine subjects the transit of the light capsule was significantly faster (P less than 0.005). It is concluded that different drug formulations can have significant effects on oesophageal transit, and hence on the development of drug induced oesophageal ulceration.

59 citations

Journal ArticleDOI
TL;DR: The usefulness of the automatic dispenser concept and acceptability of the apparatus were evaluated in patients with Parkinson's disease (PD) and it was concluded that the final version of theautomatic dose dispensing concept will offer potential for improvement of drug administration for patients with PD or other diseases requiring individual dosage.

45 citations

Journal ArticleDOI
TL;DR: It is concluded that the available literature suggests that chewable tablets provide a safe, well-tolerated alternative to traditional pediatric drug formulations and offer significant advantages in children 2 years of age and older.
Abstract: New emphasis on pediatric drug development makes the availability of safe, easy-to-use dosage formulations imperative for clinical practice. Chewable tablets are a widely used pediatric dosage form; however, a literature review on the safety of this formulation has not been published. We have, therefore, determined the safety of chewable tablets in the pediatric age group based on the published literature. A search of safety information on chewable tablets was performed from the published literature dating from January 1966 to January 1999. Search terms included tablet, chewable tablet, drug formulation, aspiration, choking, asphyxia, airway obstruction, and foreign body. Additional information was obtained from the Physician's Desk Reference, by purchasing products at a local drug store, from calls to manufacturers, and from the IMS Health National Prescription Audit Plus 7. Human, English-language studies of two types were included, clinical articles with any mention of chewable tablets, and aspiration case series. The results of this review showed that more than 60 chewable tablet formulations are approved for use in the United States. Medical issues, including foreign-body injuries, related to the chewable-tablet formulation were extremely rare. The advantages of chewable tablets include palatability, stability, precise dosing, portability, and ease of delivery. It is concluded that the available literature suggests that chewable tablets provide a safe, well-tolerated alternative to traditional pediatric drug formulations and offer significant advantages in children 2 years of age and older.

43 citations


"Acceptability of oral solid medicin..." refers background in this paper

  • ...Chewable tablets were useful in paediatric medicines for children over 2 years old (T. M. Michele et al., 2002)....

    [...]

Journal ArticleDOI
TL;DR: The results suggest that the ODTs may be of value in certain patients with PD, depending on their personal preferences, disease status, and willingness to alter an aspect of their medication use.

40 citations