Liquid Filled Hard Shell Capsules: Current Drug Delivery Influencing Pharmaceutical Technology.

PURPOSE: Gastric absorption is an upfront route for drug delivery as it is convenient, economical and most suitable for getting the desired systemic effects. Unfortunately, many traditional and newer generation drugs suffer from poor solubility and have lower bioavailability. With a perspective of bringing a novel delivery system in such a condition for old/existing/new drugs, liquidfilled hard capsules hold promise as the delivery system. METHODS: Anorganizedstate of the art literature review including patents was conducted to accommodate information on the innovations in technology, processes, and applications in the field of liquid filling in hard-shell capsules. RESULTS: The review findings revealed the importance of understanding the impact of liquid filled hard shell capsules would have in use of complex drug molecules, especially the ones sensitive to light and moisture. This technology can have diverse functions to be used for both immediate and delayed drug release. According to the technology point of view, the band sealing in such hardshell capsules helps in protecting against the tampering of capsule fill. CONCLUSION: The review provides an insight into the progression in the technology forefront related to formulation development of liquid formulations to be filled in hard shell capsules for better therapeutic potentials and convenience to the patients.

A participatory study of teenagers and young adults views on access and participation in cancer research.

PURPOSE: The purpose of this study was to elicit young people's views on access and participation in cancer research. METHODS: Eight young people aged 18-25 years with a previous cancer diagnosis aged 15-24 participated in a one day workshop utilising participatory methodology. The workshop consisted of four exercises: role play/scene setting; focus group examining thoughts and opinions of research access and participation; individual reflection on access to different types of research; and creative interpretation of the workshop. Further consultation with 222 young people with cancer was conducted using an electronic survey. RESULTS: Three themes emerged: • Patient choice: Young people thought it was their right to know all options about available research. Without knowledge of all available studies they would be unable to make an informed choice about participation. • Role of healthcare professionals as facilitators/barriers: Young people suggested non-clinical healthcare professionals such as social workers and youth support coordinators may be more suited to approaching young people about participation in psychosocial and health services research. • Value of the research: The what, when and how information was delivered was key in relaying the value of the study and assisting young people in their decision to participate. Further consultation showed approximately 70% wanted to find out about all available research. However, one third trusted healthcare professionals to decide which research studies to inform them of. CONCLUSION: Effective ways to support healthcare professionals approaching vulnerable populations about research are needed to ensure young people are empowered to make informed choices about research participation.

Development and validation of the BRIGHTLIGHT Survey, a patient-reported experience measure for young people with cancer.

BACKGROUND: Patient experience is increasingly used as an indicator of high quality care in addition to more traditional clinical end-points. Surveys are generally accepted as appropriate methodology to capture patient experience. No validated patient experience surveys exist specifically for adolescents and young adults (AYA) aged 13-24 years at diagnosis with cancer. This paper describes early work undertaken to develop and validate a descriptive patient experience survey for AYA with cancer that encompasses both their cancer experience and age-related issues. We aimed to develop, with young people, an experience survey meaningful and relevant to AYA to be used in a longitudinal cohort study (BRIGHTLIGHT), ensuring high levels of acceptability to maximise study retention. METHODS: A three-stage approach was employed: Stage 1 involved developing a conceptual framework, conducting literature/Internet searches and establishing content validity of the survey; Stage 2 confirmed the acceptability of methods of administration and consisted of four focus groups involving 11 young people (14-25 years), three parents and two siblings; and Stage 3 established survey comprehension through telephone-administered cognitive interviews with a convenience sample of 23 young people aged 14-24 years. RESULT: Stage 1: Two-hundred and thirty eight questions were developed from qualitative reports of young people's cancer and treatment-related experience. Stage 2: The focus groups identified three core themes: (i) issues directly affecting young people, e.g. impact of treatment-related fatigue on ability to complete survey; (ii) issues relevant to the actual survey, e.g. ability to answer questions anonymously; (iii) administration issues, e.g. confusing format in some supporting documents. Stage 3: Cognitive interviews indicated high levels of comprehension requiring minor survey amendments. CONCLUSION: Collaborating with young people with cancer has enabled a survey of to be developed that is both meaningful to young people but also examines patient experience and outcomes associated with specialist cancer care. Engagement of young people throughout the survey development has ensured the content appropriately reflects their experience and is easily understood. The BRIGHTLIGHT survey was developed for a specific research project but has the potential to be used as a TYA cancer survey to assess patient experience and the care they receive.

Novel participatory methods of involving patients in research: naming and branding a longitudinal cohort study, BRIGHTLIGHT.

BACKGROUND: Patient and public involvement (PPI) is central to research and service planning. Identifying effective, meaningful ways of involvement is challenging. The cohort study 'Do specialist services for teenagers and young adults with cancer add value?' follows young people for three years, examining outcomes associated with specialist care. Participant retention in longitudinal research can be problematic potentially jeopardising study completion. Maximising study awareness through high impact branding and publicity may improve study retention. Study names are typically generated by researchers rather than designed with patients. We aimed to involve young people in developing a brand identity and name to 'Do specialist services for teenagers and young adults with cancer add value?'. METHODS: Nine young people aged 17-26 years diagnosed with cancer when aged 14-25 years participated in a one day workshop with further data collection at a patient conference. Methodology was similar to conventional branding and naming exercises and was divided into six stages. The workshop comprised five stages. Stage 1: 'What's in a brand' allowed young people to enquire why brands/logos are important, Stage 2: 'Brand Transformation' identified what young people needed to know and believe about the study when approached about participation, Stage 3: 'Brand Essence' determined how we wanted the study to be perceived by young people, Stage 4: 'What's in a name' identified potential names for the study. Stage 5: 'Logo creation' assembled the mood and feel of logos. Stage 6 was logo design and an electronic survey of 249 young people attending a patient conference. RESULTS: BRIGHTLIGHT was the final study name and the brand essence (or study personality) was friendly, supportive and inspiring. Four logos were designed and the final logo received 47% (n = 115) of votes. CONCLUSIONS: Acceptance and retention to BRIGHTLIGHT is higher than anticipated (80% versus 60%), this may be related to our integral PPI strategy. We propose this reproducible methodology as an important, enjoyable, and novel way of involving patients in research and a welcome alternative to researcher-developed acronyms. Ideally this should be carried out prior to engaging with healthcare professionals to prevent confusion around study identity.