title: Application of a colorimetric technique in quality control for printed pediatric orodispersible drug delivery systems containing propranolol hydrochloride.
abstract: The feasibility of a colorimetric technique was investigated in CIELAB color space as an analytical quality control method for content uniformity of printed orodispersible pediatric delivery systems. Inkjet printing was utilized to fabricate orodispersibe film formulations containing propranolol hydrochloride in a colored ink base using three different edible substrates. A thin sweetener coating layer of saccharin was successfully included in the final dosage forms for palatability purposes using a casting knife. Optical microscopy, scanning electron microscopy and scanning white light interferometry analyses were conducted to study the effect of printing on the surface morphology and topography of the substrates. Differential scanning calorimetry and attenuated total reflectance infrared spectroscopy were used to study the solid state properties and possible interactions between the drug and the excipients. The inkjet printing technique deposited precise and uniform escalating doses (0.08-3.16mg) of the active pharmaceutical ingredient onto the substrates (R(2)≥0.9934). A disintegration test with clear end-point detection confirmed that all the substrates meet the requirements of the Ph. Eur. to disintegrate within 180s. The colorimetric technique proved to be a reliable method to distinguish the small color differences between formulations containing an escalating dose of propranolol hydrochloride.
authors.affiliation: Pharmaceutical Sciences Laboratory, ÿbo Akademi University, Tykistökatu 6A, FI-20540 Turku, Finland. Electronic address: hvakili@abo.fi.
authors.forename: Hossein
authors.initials: H
authors.lastname: Vakili
authors.affiliation: Pharmaceutical Sciences Laboratory, ÿbo Akademi University, Tykistökatu 6A, FI-20540 Turku, Finland.
authors.forename: Johan O
authors.initials: JO
authors.lastname: Nyman
authors.affiliation: Department of Pharmacy, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen, Denmark.
authors.forename: Natalja
authors.initials: N
authors.lastname: Genina
authors.affiliation: Pharmaceutical Sciences Laboratory, ÿbo Akademi University, Tykistökatu 6A, FI-20540 Turku, Finland.
authors.forename: Maren
authors.initials: M
authors.lastname: Preis
authors.affiliation: Pharmaceutical Sciences Laboratory, ÿbo Akademi University, Tykistökatu 6A, FI-20540 Turku, Finland.
authors.forename: Niklas
authors.initials: N
authors.lastname: Sandler
mesh_terms: D000284:Administration, Oral; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000737:chemistry / Q000592:standards; D003124:Colorimetry / Q000379:methods; D004396:Coloring Agents / Q000008:administration & dosage / Q000737:chemistry / Q000592:standards; D004339:Drug Compounding / Q000379:methods / Q000592:standards*; D016503:Drug Delivery Systems / Q000379:methods*; D010372:Pediatrics / Q000379:methods; D066330:Printing, Three-Dimensional / Q000592:standards*; D011433:Propranolol / Q000008:administration & dosage* / Q000737:chemistry / Q000592:standards*; D011786:Quality Control
chemical_list: D000319:Adrenergic beta-Antagonists; D004396:Coloring Agents; D011433:Propranolol
keywords: CIELAB; Colorimetry; Glycerol (PubChem CID: 753); Hydrochloric acid (PubChem CID: 313); Hydroxypropyl cellulose (PubChem CID: 123706); Inkjet printing; Orodispersible formulations; Pediatric drug delivery; Personalized medicine; Potassium dihydrogen phosphate (PubChem CID: 516951); Propranolol hydrochloride (PubChem CID: 62882); Saccharin sodium salt hydrate (PubChem CID: 24899456)