A Functional Assay to Measure the T Cell Response to Sars-Cov-2 in Primary Immunodeficiency Patients

ABSTRACT

Background/Aims Effective symptom management may require the use of medications. Medication adherence may be hindered by formulation aspects, such as poor taste. Paediatric studies indicate, that despite concerns of swallowing solid dose forms, children prefer these to liquid forms. They find the solid dose forms more palatable. However, swallowing numerous solid dose forms, may present a significant 'pill' burden to patients and their care-givers. Filling empty gelatine capsules with requisite medications is seen and used as a way to address palatability, decrease pill burden and thereby increase compliance. Yet there is little evidence on the impact this practise may have on the effectiveness of over-encapsulated medicines. This study explored the effect of over-encapsulation on in vitro disintegration and dissolution, of some commonly used medicines in paediatric palliative care. Method Immediate release (Cyclizine Hydrochloride, Gabapentin, Paracetamol) and modified release preparations (Omeprazole, Diclofenac sodium) were over-encapsulated in size 00 gelatin and HPMC capsules (n=6). Dissolution and disintegration were tested according to Pharmacopeia standards. Statistical analyses, using Student's T-test and f1 and f2 tests (respectively) were applied to determine similarities or differences in disintegration or dissolution. Results Disintegration and dissolution was prolonged for all over-encapsulated immediate release preparations, especially when using HPMC capsules. However, percentage of drug dissolved met the acceptance criteria for immediate-release solid oral dosage. Over-encapsulation of modified release preparations did not lead to significant dissolution or disintegration changes. Conclusion Over-encapsulation, may delay medication release, especially for immediate release medicines however, medicine effectiveness may not be. Further studies are required before we can safely recommend use of over-encapsulation as an administration compliance aid.