ABSTRACT
Dexibuprofen (DXIBN) transdermal patches were formulated using various concentrations of selected polymeric excipients (matrix material; ethyl cellulose and polyvinylpyrrolidone, plasticizer (di-N-butyl phthalate), and a conventional permeation enhancer (almond oil)). Initial patch formulations were evaluated for their physiochemical properties (thickness, moisture uptake, final moisture content, and DXIBN content). Also, impact of patch components on resulting tensile strength and in vitro permeation were used to predict an optimal patch formulation using a quality-by-design (QbD) approach, which was subsequently evaluated and further compared with a commercial oral tablet dosage form for in vitro and in vivo release (rabbit model). Initially formulated patches demonstrated uniform thickness (0.44 ± 0.02 cm), relatively low moisture uptake (7.87 ± 1.11 w/w %), and highly acceptable drug loading values (100.0 ± 0.026%). The tensile strength of patches increased significantly with matrix polymer concentration and to a lesser degree with increase in plasticizer and permeation enhancer content, although these affected the permeation of DXIBN. Predicted properties (tensile strength and DXIBN steady-state flux) for the QbD-optimized formulation were in close agreement to experimental results. The QbD optimal patch formulation behavior differed significantly from the commercial tablet formulation in vivo. Such model-based predictions (QbD approach) will reduce cost and time in formulation development sciences.
Subject(s)
Antirheumatic Agents/administration & dosage , Drug Carriers/chemistry , Drug Design , Ibuprofen/analogs & derivatives , Skin/metabolism , Transdermal Patch/standards , Animals , Antirheumatic Agents/pharmacokinetics , Drug Compounding , Drug Liberation , Ibuprofen/administration & dosage , Ibuprofen/pharmacokinetics , Plasticizers/chemistry , Polymers/chemistry , Rabbits , Skin/drug effects , Skin Absorption , Skin Irritancy Tests , Solubility , Surface Properties , Tensile StrengthABSTRACT
BACKGROUND: Removing dental plaque may play a key role in maintaining oral health. Methods for oral hygiene vary from country to country and from culture to culture. Chewing sticks (miswak) and toothpowders are popular oral hygiene tools in Pakistan. OBJECTIVE: To compare the plaque-removing efficacy of toothpaste and toothpowder with and without manual toothbrushes. MATERIALS AND METHODS: The study was designed as an examiner-blind crossover study. The Silness and Löe plaque index was used to evaluate the plaque distribution. Thirty-six volunteer dental students were recruited for the experiment. After scoring, the subjects were randomly divided into two groups. The first group was asked to brush with toothpaste or toothpowder according to a split mouth protocol. The second group was asked to follow the same protocol except they were asked to use their finger instead of the brush. The remaining plaque was scored again. RESULTS: Plaque-removing efficacy of the toothpowder was higher whether it was used with brush or with finger. There was a significant difference between paste and powder users (p = 0.009). CONCLUSION: The results of this study indicate that toothpowder is an effective means to remove plaque with a brush.
