Comparative binder efficiency modeling of dry granulation binders using roller compaction.
Drug Dev Ind Pharm. 2017 Apr;43(4):574-583. doi: 10.1080/03639045.2016.1272118. Epub 2017 Jan 5. Gupte A1, DeHart M1, Stagner WC2, Haware RV2. Author information 1 a Mayne Pharma Inc , Greenville , NC , USA. 2 b Campbell University College of Pharmacy & Health Sciences , Buies Creek , NC , USA. Abstract Roller compaction parameters’ impact on granules and tableting […]
Crospovidone and Microcrystalline Cellulose: A Novel Description of Pharmaceutical Fillers in the Gastrointestinal Tract.
Am J Surg Pathol. 2017 Apr;41(4):564-569. doi: 10.1097/PAS.0000000000000790. Shaddy SM1, Arnold MA, Shilo K, Frankel WL, Harzman AE, Stanich PP, Singhi AD, Yearsley MM, Arnold CA. Author information 1 Departments of *Pathology ‡Surgery §Division of Gastroenterology, Hepatology & Nutrition, The Ohio State University Wexner Medical Center †Department of Pathology and Laboratory Medicine, Nationwide Children’s Hospital, Columbus, OH ∥Department of Pathology, University of Pittsburgh Medical […]
Effect of experimental design on the prediction performance of calibration models based on near-infrared spectroscopy for pharmaceutical applications.
Abstract Near-infrared spectroscopy (NIRS) is a valuable tool in the pharmaceutical industry, presenting opportunities for online analyses to achieve real-time assessment of intermediates and finished dosage forms. The purpose of this work was to investigate the effect of experimental designs on prediction performance of quantitative models based on NIRS using a five-component formulation as a […]
Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization.
Abstract The aim of this study was to prepare fast disintegrating combination tablet of taste masked Levocetrizine dihydrochloride and Montelukast sodium by using direct compression method. To prevent bitter taste and unacceptable odour of the Levocetrizine dihydrochloride drug, the drug was taste masked with ion exchange resins like Kyron-T-104 and Tulsion-412. Among the two resins, […]
Functionality of disintegrants and their mixtures in enabling fast disintegration of tablets by a quality by design approach.
Abstract Investigation of the effect of disintegrants on the disintegration time and hardness of rapidly disintegrating tablets (RDTs) was carried out using a quality by design (QbD) paradigm. Ascorbic acid, aspirin, and ibuprofen, which have different water solubilities, were chosen as the drug models. Disintegration time and hardness of RDTs were determined and modeled by […]
[Influence of polymer type on the physical properties and the release study of papaverine hydrochloride from tablets].
Abstract BACKGROUND: Polymers are widely used in drug manufacturing. Researchers studied their impact on the bioavailability of active substances or on physical properties of tablets for many years. OBJECTIVES: To study the influence of polymer excipients, such as microcrystalline cellulose (Avicel PH 101, Avicel PH 102), croscarmellose sodium, crospovidone or polyvinylpyrrolidone, on the release profile […]
Modulation of microenvironmental pH and utilization of alkalizers in crystalline solid dispersion for enhanced solubility and stability of clarithromicin.
Abstract Clarithromycin (CAM) is known to be poorly water-soluble and acid-labile drug. Various alkalizers such as MgO, Na2CO3, Na2HPO4 and NaHCO3 were utilized to modulate the microenvironmental pH (pHM) and to improve the low stability and solubility of CAM in a crystalline-solid dispersion system (CSD). Polyvinylpyrrolidone (PVP K-30) and hydroxypropylmethylcellulose (HPMC) 4000-based CSDs containing alkalizers […]
Optimization of Time Controlled 6-mercaptopurine Delivery for Site- Specific Targeting to Colon Diseases.
Abstract BACKGROUND: 6-MP has short elimination time (<2 h) and low bioavailability (~ 50%). Present study was aimed to develop time controlled and site targeted delivery of 6-Mercaptopurine (6-MP) for treatment of colon diseases. METHODS: Compression coating technique was used. 32 full factorial design was designed for optimization of the outer coat for the core […]
The Disintegration Process in Microcrystalline Cellulose Based Tablets, Part 1: Influence of Temperature, Porosity and Superdisintegrants.
Abstract Disintegration performance was measured by analysing both water ingress and tablet swelling of pure microcrystalline cellulose (MCC) and in mixture with croscarmellose sodium using terahertz pulsed imaging (TPI). Tablets made from pure MCC with porosities of 10% and 15% showed similar swelling and transport kinetics: within the first 15 s, tablets had swollen by up to […]
Assessment of powder blend uniformity: Comparison of real-time NIR blend monitoring with stratified sampling in combination with HPLC and at-line NIR Chemical Imaging.
Abstract Scope of the study was (1) to develop a lean quantitative calibration for real-time near-infrared (NIR) blend monitoring, which meets the requirements in early development of pharmaceutical products and (2) to compare the prediction performance of this approach with the results obtained from stratified sampling using a sample thief in combination with off-line high […]