Comparison of Three Dissolution Apparatuses for Testing Calcium Phosphate Pellets used as Ibuprofen Delivery Systems

Abstract

Abstract. Porous calcium phosphate pellets were produced according to two granulation processes (low and high shear wet granulations) and drug loaded with five ibuprofen contents (1.75%, 7%, 12.5%, 22%, and 36%) in order to ensure both bone defect filling and local drug delivery. The drug-release kinetics from the two types of pellets was studied using three dissolution apparatuses: paddle apparatus, reciprocating cylinder, and flow-through cell. The paper compared the three dissolution methods and considered the effect of the granulation process on the ibuprofen-release kinetics. Dissolution data were analyzed using the Weibull function as well as the difference (f1) and similarity (f2) factors. Dissolution kinetics was not influenced by the granulation process, regardless of the dissolution apparatus and of the drug content. The comparison of the three dissolution devices indicated that ibuprofen was released faster from granules loaded with 36% of drug content with the reciprocating apparatus, due to the disintegration of the granules occurring during the dissolution test. For the other drug contents, dissolution profiles were not significantly different from one apparatus to another. However, the flowthrough cell seemed to be more suitable for the drug-release study of implantable materials.

Dissolution Model Development: Formulation Effects and Filter Complications

“…All experiments were conducted at 37 ± 0.5 °C and a paddle rotation speed of 50 rpm. Plastic syringes (5 mL) connected to a stainless steel sampling device were used for manual sampling at fixed sampling times (2,4,6,8,10,15,30, and 60 min). Sample preparation consisted of a single filtration step discarding the first 1 mL followed by centrifugation for 10 min at 15,000 rpm and appropriate dilution before analysis by high performance liquid chromatography (HPLC).…”

“…Among others, the choice of apparatus, dissolution medium, and sample preparation are all factors that will directly impact the dissolution profiles (2)(3)(4).…”

Development of a Dissolution Test for Extended-Release Bromopride Pellets with In Vivo–In Vitro Correlation

“…This correlation is a predictive mathematical model that describes the relationship between in vitro dissolution and drug absorption over time (20). Several dissolution apparatus were used during the development of the dissolution method using IVIVC; however, the reciprocating cylinder or BioDis (Apparatus 3) was designed especially for evaluating ER (24)(25)(26). BPD is a Class 2 drug, and its absorption is primarily limited by its dissolution rate.…”

β-TCP porous pellets as an orthopaedic drug delivery system: ibuprofen/carrier physicochemical interactions

“…Such drug delivery system can also be used for the local treatment of articular inflammatory pathologies such as arthritis. In previous studies [18][19][20][21][22], porous β-TCP pellets were produced by high-shear wet granulation and loaded with ibuprofen by solvent evaporation method. The spherical form and the size of these implants, 900 µm in diameter, can guarantee the filling of complex-shaped bone cavities, while maintaining intergranular spaces of about 180 µm for bone ingrowth.…”

“…β-TCP porous pellets were fabricated by wet high shear granulation as in previous works [18][19][20][21][22]. The obtained pellets were loaded through impregnation: they were soaked in ibuprofen solutions, separated from their supernatant and then dried under ambient conditions.…”