Pharmaceutical Packaging: Investigation into older patient centered design Ease of opening - target group studies based on CEN/TS 15945 Pharmaceutical Technology and Packaging Science 1 Content Pharmaceutical Packaging: Investigation into older patient centered design CEN/TS 15945: Normative Target Group Test Comparative study of aluminum-aluminum type blister vs. PVCaluminum type blister Evaluation of possible correlation of ease of opening with measured extraction forces Follow-up studies to define and evaluate design factors for the ease of opening of blister packaging for solid dosage forms Transparancy Geometrical fit of dosage form Vitamin Supplement Drinks Packaging Concepts Influence of education methods 2
CEN/TS 15945 CEN/TS 15945 A three step test 1. Opening Effectivity A test person has to open one package within 5 minutes 2. Opening Efficiency A second (identical) package must be opened within 1 minute 3. Patient / Consumer Satisfaction A portion of the product must be taken out of the second package and packaging must be reclosed (if applicable) within 5 minutes (including second opening ) After repeated opening the users rate their satisfaction on a scale from 2 to +2 Acceptable, if satisfaction is rated with at least 0 3 CEN/TS 15945 Age range Target Group Test subject to CEN/TS 15945 Sequential method Number of Target Group Participants Number of Successfull Opening Procedures Number of Failed Opening Procedures Confidence Interval (%) 20 20 0 85 to 100 40 38 2 82 to 99 60 56 4 83 to 97 80 75 5 85 to 97 100 94 6 87 to 97 4
CEN/TS 15945 Target Group Test subject to CEN/TS 15945 Target Group Test Design + Kitchen-Table-Scenario Autonomous Lifestyle Video analysis of hand movements Detailed evaluation of packaging concept challanges 5 Modelling of Opening Procedures Human factors for easy opening 6
Initial Study Comparative study of aluminum-aluminum type blister vs. PVC-aluminum type blister Evaluation of possible correlation of ease of opening with measured extraction forces 7 Initial Study - Effectivity Time to Open Alu-Alu-Blister vs. PVC-Alu-Blister effectivity by age groups Alu-Alu PVC-Alu opening time [sec] abort 10 12 6 8 4 6 2 4 age group [years] 65 70 71 75 76 80 0 2 15 10 5 0 5 10 15 number of participants 8
Initial Study Patient Satisfaction Patient Satisfaction Alu-Alu-Blister vs. PVC-Alu-Blister satisfaction by age groups Alu-Alu PVC-Alu contentment +2 +1 0 1 age group [years] 65 70 71 75 76 80 2 15 10 5 0 5 10 15 number of participants 9 Initial Study - Conclusions Lower opening forces for alu-alu blisters, however increased opening time in target group study reduced patient satisfaction 10
Initial Study - Conclusions Tablet in aluminium-aluminium blister has more space in the larger cavity for coincidential movements Intransparency of alu-alu blisters inhibits the patient to execute a specific pressure movement, as tablet s position cannot be observed Pressure is applied randomly! 11 Follow-up Studies Follow-up studies to define and evaluate design factors for the ease of opening of blister packaging for solid dosage forms Transparency Geometrical fit of dosage form 12
Transparency Evaluation of Transparency 13 Transparency Evaluation of Transparency opening time: opaque film vs. transparent film > 9 8 9 6 7 transparent film opaque film age group [years] 65 70 opening time [sec] 4 5 2 3 0 1 71 75 76 80 15 10 5 0 5 10 15 number of participants 14
Transparency Evaluation of Transparency transparent film opaque film patient satisfaction: transparent film vs. opaque film contentment 2 1 0-1 -2 age group [years] 65-70 71-75 76-80 15 10 5 0 5 10 15 number of participants 15 Geometrical Fit Evaluation of Geometrical Fit Views of studied tablet dimensions: 20x3 mm (left), 16x7 mm (middle) 20x8 mm (right) 16
Geometrical Fit Evaluation of Geometrical Fit 17 Geometrical Fit Evaluation of Geometrical Fit - Tablet 16x7 mm - Views of tablet 16x7 mm and blister stripe 18
Geometrical Fit Evaluation of Geometrical Fit - Tablet 16x7 mm - effectivity tablets 16x7 efficiency Median effectivity 2,69 sec Median efficiency 2,17 sec opening time [sec] > 10 8-10 6-8 4-6 2-4 age group [years] 65-69 70-74 75-80 0-2 10 5 0 5 10 number of participants 19 Geometrical Fit Evaluation of Geometrical Fit - Tablet 20x8 mm - Views of tablet 20x8 mm and blister stripe 20
Geometrical Fit Evaluation of Geometrical Fit - Tablet 20x8 mm - effectivity tablets 20x8 efficiency Median effectivity 3,42 sec Median efficiency 2,17 sec opening time [sec] > 10 8-10 6-8 4-6 2-4 age group [years] 65-69 70-74 75-80 0-2 10 5 0 5 10 number of participants 21 Geometrical Fit Evaluation of Geometrical Fit - Tablet 20x3 mm - Views of tablet 20x3 mm and blister stripe 22
Geometrical Fit Evaluation of Geometrical Fit - Tablet 20x3 mm - Median effectivity 5,09 sec Median efficiency 4,78 sec opening time [sec] > 10 8-10 6-8 4-6 2-4 effectivity tablets 20x3 efficiency age group [years] 65-69 70-74 75-80 0-2 8 6 4 2 0 2 4 6 8 number of participants 23 Geometrical Fit Evaluation of Geometrical Fit Tablets satisfaction rating 10 10 10 9 9 9 8 8 8 number of participants 7 6 5 4 3 2 1 0-2 -1 0 1 2 7 6 5 4 3 2 1 0-2 -1 0 1 2 7 6 5 4 3 2 1 0-2 -1 0 1 2 age group [years] 65-69 70-74 75-80 contentment rate contentment rate contentment rate tablets 16x7, median=1.15 tablets 20x3, median=0.20 tablets 20x8, median=1.35 24
General Design Recommendations Cavities should not be too large Cavity well tuned to tablet size and shape Rigidity of packaging material must be suitable for dosage form Transparent film: Visibility of tablet is helpful One Size does not fit all! 25 Vitamin Supplement Drinks 26
Vitasprint Opening of Vitasprint 27 Vita-Kick Opening of Vita-Kick
Vitamin Supplement Drinks Familiarity with Packaging Concept Vitasprint Vita-Kick 5% 20% 20% knwon not known not sure known not known not sure 75% 80% 20% of participants mistake it for eye-drops or other pharmaceutical 29 Vitamin Supplement Drinks Correctness of Opening Procedure Vitasprint Vita-Kick 10% 15% 5% wrong opening procuedure 90% correct opening wrong opening 80% correct opening aborted 35% of participants mistake plug of powder compartment as opening aid 30
Vitamin Supplement Drinks Vitasprint New Study 2017 Perceived increased media presents with embedded opening instructions, e. g. TV spots Reported increased activity of sales force encouraging pharmacists to explain packaging 31 Vitamin Supplement Drinks Vitasprint Comparision of Studies Number of Participants 20 18 16 14 12 10 8 6 4 2 0 Opening Procedure 14 18 6 2 Study 2016 Study 2017 Wrong Opening Procedure Correct Opening Procedure 32
Vitamin Supplement Drinks Vitasprint Comparision of Studies Study 2016 known, correct opening 14 1 1 3 1 known, wrong opening not known, correct opening not known, wrong opening not sure, aborted 8 1 3 Study 2017 5 known, correct opening known, wrong opening not known, correct opening not known, wrong opening 3 not sure, wrong opening 33 Vitamin Supplement Drinks Vitasprint Opening Instructions Opening Instructions 20 18 Number of Participants 16 14 12 10 8 6 12 3 No Yes, not helpful Yes, helpful 4 2 5 0 Opening Instructions found 34
Vitamin Supplement Drinks Vitasprint Comparision of Studies Conclusion Complex packaging or application aids require professional education, instruction or assistance by pharmacists! 35 Literature Prüfung und Evaluation von leicht zu öffnenden Verbraucherverpackungen; M. Braun-Münker, F. Ecker, M. Wrogemann; Deutsche Lebensmittel Rundschau, April 2014, 110. Jahrgang; S. 181 184 Eine für alle? Verpackungen von Tabletten; F. Ecker, M. Braun-Münker, U. Weingärtner; Pharmazeutische Zeitung; PZ 37/2014; S. 50 57 Prüfung von Verpackungen auf leichte Handhabbarkeit korrelieren instrumentelle Verfahren mit Zielgruppenprüfungen?; M. Wrogemann, M. Braun-Münker, F. Ecker; pharmind die pharmazeutische Industrie; 77, Nr. 1, (2015); ECV Vergleichende Untersuchung zum Öffnungsverhalten von Stickpacks; F. Meissner, M. Braun-Münker, F. Ecker; pharmind - die pharmazeutische Industrie; 77, Nr. 8, (2015); ECV Verbrauchergerechte Milchverpackungen im Test; M. Braun-Münker, T. Turwitt, F. Ecker; Deutsche Molkerei Zeitung; 136. Jahrgang, 12.11.15; AVA-Agrar Verlag Allgäu GmbH, Kempten/Allgäu Leichtes Öffnen von Wurstverpackungen - Zielgruppenprüfung nach CEN/TS 15945 zur Handhabbarkeit unterschiedlicher Verpackungen von gestapelter Wurst; M. Braun-Münker, A. Günther, F. Ecker; Fleischwirtschaft -Frankfurt- 2015 (95. Jahrgang) Nr.12 S.103-105 Drehmomente; M. Braun-Münker, T. Turwitt, F. Ecker; Milch-Marketing; 02/2016, S. 22-24 Von wegen einfach! Wie erklärungsbedürftige Verpackungen Patienten herausfordern; M. Braun-Münker, F. Ecker, A. Günther; Deutsche Apotheker Zeitung; 156. Jahrgang; 28.04.2016; Nr. 17; S. 30-33 Leichtes Öffnen von Obstkonserven Zielgruppenprüfungen nach CEN/TS 15945 zur Handhabbarkeit von unterschiedlichen Obstkonserven; Simone Sohnle, Myriam Braun-Münker und Felix Ecker; Deutsche Lebensmittel-Rundschau, DLR; Mai 2016 (112. Jahrgang) S. 217-219 Vergleichende Untersuchung von diversen Schraubverschlüssen gibt es eine Korrelation zwischen den Ergebnissen der Zielgruppenprüfung und der instrumentellen Messung? A comparative study of various screw caps. Is there any correlation between the results of a target group study and instrumental measurement? Simone Sohnle, Myriam Braun-Münker, Felix Ecker (2016) Ernährungs Umschau; 63(9): 186-191, DOI:10.4455/eu2016.039 Ease of Opening of Blistered Solid Dosage Forms in a Senior Citizens Target Group; Myriam Braun-Münker, Felix Ecker; Int J Pharmaceut 512 (2016) 412-415, DOI:10.1016/j.ipharm2015.10.063 Leichtes Öffnen von Keksverpackungen Zielgruppenprüfung nach CEN/TS 15945 zur Handhabbarkeit; Simone Sohnle, Myriam Braun- Münker, Felix Ecker (2016) LVT Lebensmittelindustrie; Ausgabe 11: 26-29 Fischkonserven leichter öffnen Zielgruppenprüfungen nach CEN/TS 15945 zur Handhabbarkeit von Fischdosen; Simone Sohnle, Myriam Braun-Münker, Felix Ecker (2016) Neue Verpackung, Ausgabe 11: 50-51 Der richtige Dreh, Erklärungsbedürftige Verpackungen fordern den Patienten und eine gute Beratung; M. Braun-Münker, M. Uhlig, F. Ecker; Deutsche Apotheker Zeitung; 157. Jahrgang; 09.11.2017; Nr. 45; S. 30-31 36