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AAPS PharmSciTech

David W Osborne, Jasmine Musakhanian
A heightened interest in (trans)dermal delivery is in part driven by the need to improve the existing skin therapies and also the demand for alternative routes of administration, notably for pharmaceutical actives with undesirable oral absorption characteristics. The premise of delivering difficult actives to the skin or via the skin however is weighed down by the barrier function properties of the stratum corneum. Short of disrupting the skin by physical means, scientists have resorted to formulation with excipients known to enhance the skin penetration and permeation of drugs...
November 12, 2018: AAPS PharmSciTech
Ana Patricia Ferreira, John F Gamble, Michael M Leane, Hyunsoo Park, Dolapo Olusanmi, Mike Tobyn
The impact of pharmaceutical materials properties on drug product quality and manufacturability is well recognised by the industry. An ongoing effort across industry and academia, the Manufacturing Classification System consortium, aims to gather the existing body of knowledge in a common framework to provide guidance on selection of appropriate manufacturing technologies for a given drug and/or guide optimization of the physical properties of the drug to facilitate manufacturing requirements for a given processing route...
November 8, 2018: AAPS PharmSciTech
Joseph W Polli, Christopher R McCurdy, Dale Eric Wurster, Binodh S DeSilva, Annette Bak, Reina Bendayan, Bernd Meibohm, Allen C Templeton, William Weiser
No abstract text is available yet for this article.
November 3, 2018: AAPS PharmSciTech
Usama A Fahmy
Statins are commonly used in the middle-aged and elderly people for treatment of hyperlipidemia. Both alpha lipoic acid (ALA) and ellagic acid (EA) are natural antioxidants found in a normal diet. They can protect against cellular damage and induce cellular apoptosis in many types of cancer cells. Fluvastatin (FLV) was combined with ALA and EA in a nanostructured lipid carrier (NLC) formula. The prepared NLCs were imaged with a transmission electron microscope (TEM). Particle size and zeta potential and FLV entrapment efficiency (%EE) were measured, and the FLV release profile was constructed...
October 22, 2018: AAPS PharmSciTech
Vivian A Gray
For a dissolution method to be considered relevant to in vivo performance, the dissolution data profiles should show discrimination or meaningful change when there is a change in critical material attributes (CMAs) and critical product properties (CPPs). The dissolution test has been shown repeatedly to have the power to distinguish between significant changes in active pharmaceutical ingredient (API), formulation, and process that relate to the release mechanism of the in vivo performance. Examples will be discussed in the literature where the effects of formulation, drug substance, and manufacturing variables have been measured by dissolution testing...
October 22, 2018: AAPS PharmSciTech
Jing Chen, Yue Tang, Yun Liu, Yushun Dou
Nucleic acid-based therapeutics present huge potential in the treatment of pulmonary diseases ranging from lung cancer to asthma and chronic pulmonary diseases, which are often fatal and widely prevalent. The susceptibility of nucleic acids to degradation and the complex structure of lungs retard the effective pulmonary delivery of nucleic acid drug. To overcome these barriers, different strategies have been exploited to increase the delivery efficiency using chemically synthesized nucleic acids, vector encapsulation, proper formulation, and administration route...
October 18, 2018: AAPS PharmSciTech
Qiuyu Wei, Qiuxuan Yang, Qilong Wang, Congyong Sun, Yuan Zhu, Ya Niu, Jiangnan Yu, Ximing Xu
In this study, an optimized nanostructured lipid carriers (NLCs) were developed and investigated for improving the solubility and oral availability of 6-Gingerol (6G), an active and abundant component of ginger with limited applications due to its poor water solubility plus oral biological availability. The NLCs consisted of a solid lipid (glyceryl monostearate), another liquid lipid (decanoyl/octanoyl-glycerides) and mixed surfactants (Tween 80 and Poloxamer 188), and was prepared by high pressure homogenization method...
October 15, 2018: AAPS PharmSciTech
Ousama Rachid, Keith J Simons, Mutasem Rawas-Qalaji
In community settings, IM injection of 0.3 mg epinephrine (Epi) using an auto-injector is the drug of choice for treatment of anaphylaxis. Previously, a taste-masking (TM) formulation of fast-disintegrating sublingual tablets (FDSTs) was developed in our lab. Also, Epi was micronized (Epi-MC) successfully and reduced the previously achieved bioequivalent sublingual Epi dose to 0.3 mg IM injection by half using non-taste-masked fast-disintegrating sublingual tablets (TM-FDSTs). Our objective for this study was to evaluate the sublingual absorption of Epi-MC using TM-FDST...
October 15, 2018: AAPS PharmSciTech
Xin-Lu Liu, Hong-Fei Yao, Mei-Hong Chai, Wei He, Yan-Ping Huang, Zhao-Sheng Liu
The facile fabrication of single-walled carbon nanotubes (SWCNTs)-doping molecularly imprinted polymer (MIP) nanocomposite-based binary green porogen system, room-temperature ionic liquids (RTILs), and deep eutectic solvents (DESs) was developed for drug delivery system. With fenbufen (FB) as template molecule, 4-vinylpyridine (4-VP) was used as functional monomer, ethylene glycol dimethacrylate as cross-linking monomer, and 1-butyl-3-methylimidazoliumtetrafluoroborate and choline chloride/ethylene glycol as binary green solvent, in the presence of SWCNTs...
October 15, 2018: AAPS PharmSciTech
Mary Joseph Ngatuni, Hoang M Trinh, Dhananjay Pal, Ashim K Mitra
The objective of this study is to design, develop, and synthesize novel random triblock (RTB) copolymers for sustained delivery of macromolecules. RTB copolymers have not been utilized for the delivery of macromolecules for ocular diseases. RTB copolymers comprising of polyethylene glycol, glycolide, and ɛ-caprolactone blocks were synthesized and assessed for their molecular weights and purity using 1 H-NMR spectroscopy, gel permeation chromatography, FTIR (functionality), and XRD (crystallinity). No toxicity was observed when ocular cell lines were treated with RTB copolymers...
October 10, 2018: AAPS PharmSciTech
Ameneh Almasi, Soraya Shahhosseini, Azadeh Haeri, Fariba Johari Daha, Parham Geramifar, Simin Dadashzadeh
Nanocarriers radiolabeled with [99m Tc] can be used for diagnostic imaging and radionuclide therapy, as well as tracking their pharmacokinetic and biodistribution characteristics. Due to the advantages of niosomes as an ideal drug delivery system, in this study, the radiolabeling procedure of niosomes by [99m Tc]-HMPAO complexes was investigated and optimized. Glutathione (GSH)-loaded niosomes were prepared using a thin-film hydration method. To label the niosomes with [99m Tc], the preformed GSH-loaded niosomes were incubated with the [99m Tc]-HMPAO complex and were characterized for particle size, size distribution, zeta potential, morphology, and radiolabeling efficiency (RE)...
October 5, 2018: AAPS PharmSciTech
Gregor Podrekar, Domen Kitak, Andraž Mehle, Zoran Lavrič, Boštjan Likar, Dejan Tomaževič, Rok Dreu
Film coating thickness of minitablets was estimated in-line during coating in a fluid-bed equipment by means of visual imaging. An existing, commercially available image acquisition system was used for image acquisition, while dedicated image analysis and data analysis methods were developed for this purpose. The methods were first tested against simulated minitablet's images and after that examined on a laboratory-scale fluid-bed Wurster coating process. An observation window cleaning mechanism was developed for this purpose...
October 2, 2018: AAPS PharmSciTech
Reham Waheed Hammad, Rania Abdel Baset Sanad, Nevine Shawky Abdelmalk, Randa Latif Aziz, Faisal A Torad
Gastroesophageal reflux disease (GERD) is an esophageal injury occurred when the stomach contents reflux abnormally into the esophagus. GERD complications include esophageal adenocarcinoma. Mosapride (MOS) is a safe prokinetic agent potentially used to treat GERD. Yet, its low solubility and bioavailability due to extensive first-pass metabolism limits its applications. This study aimed to formulate MOS nanostructured lipid carriers (MOS-NLCs) via the intranasal route to improve its bioavailability. Melt-emulsification low temperature-solidification technique using 23 full factorial design was adopted to formulate MOS-NLCs...
October 2, 2018: AAPS PharmSciTech
G S Ravi, R Narayana Charyulu, Akhilesh Dubey, Prabhakara Prabhu, Srinivas Hebbar, Avril Candida Mathias
The current study was aimed to develop an amphiphilic drug-lipid nano-complex of rutin:egg phosphatidylcholine (EPC) to enhance its poor absorption and bioavailability, and investigated the impact of the complex on hepatoprotective and antioxidant activity. Rutin nano-complexes were prepared by solvent evaporation, salting out and lyophilisation methods and compared for the complex formation. For the selected lyophilisation method, principal solvent DMSO, co-solvent (t-butyl alcohol) and rutin:EPC ratios (1:1, 1:2 and 1:3) were selected after optimisation...
October 2, 2018: AAPS PharmSciTech
Bhavin Y Gajera, Dhaval A Shah, Rutesh H Dave
The hot melt extrusion (HME) technology was explored and optimized to solidify an amorphous nanosuspension using Quality by Design (QbD) methodology. A design of experiments (DoE) approach was used to perform a set of 15 experiments, varying independent variables (feed rate, input temperature, and screw speed) within a design space. Redispersibility index (RDI), moisture content, and process yield constituted the critical quality attributes (CQAs) of the experimental design. Regression analysis and ANOVA were employed to identify and estimate significant main effects and two-way interactions, and model the process of HME drying for predictive purposes...
October 2, 2018: AAPS PharmSciTech
Dherya Bahl, Aditya B Singaraju, Lewis L Stevens
Describing the elastic deformation of single-crystal molecular solids under stress requires a comprehensive determination of the fourth-rank stiffness tensor (Cijkl ). Single crystals are, however, rarely utilized in industrial applications, and thus averaging techniques (e.g., the Voigt or Reuss approach) are employed to reduce the Cijkl (or its inverse Sijkl ) to polycrystalline aggregate mechanical moduli. With increasing elastic anisotropy, the Voigt and Reuss-averaged aggregate moduli can diverge dramatically and, provided that drug molecules almost exclusively crystallize into low-symmetry space groups, warrants a significant need for accurate aggregate mechanical moduli...
October 2, 2018: AAPS PharmSciTech
Jorge Alberto S Moreno, Danai-Anastasia Panou, Karen Stephansen, Ioannis S Chronakis, Anja Boisen, Ana C Mendes, Line Hagner Nielsen
Chitosan particles loaded with the antigen ovalbumin (OVA) and the adjuvant Quil-A were produced by electrospray, using mixtures of water/ethanol/acetic acid as a solvent. Three different chitosans designed as HMC+ 70, HMC+ 85, and HMC+ 90 (called as 705010, 855010, and 905010) were tested and its efficacy to be used in oral vaccine delivery applications was investigated. The morphology, size, and zeta potential of the produced particles were investigated, together with the encapsulation efficiency and release of OVA from the three chitosan formulations...
October 2, 2018: AAPS PharmSciTech
Jia Zeng, Jianxing Chen, Liangkang Chen, Wei Zheng, Yunfeng Cao, Ting Huang
Chlormadinone acetate (CMA) is a derivative of the naturally secreted hormone progesterone and exhibits reliable contraceptive and non-contraceptive benefits. Although the marketed product of CMA as oral tablets under the trade name Belara® has been highly successful, there is still room for further improvements in oral bioavailability and a reduction in the clinical dose to decrease related adverse effects. In the current study, a CMA-based self-microemulsifying drug delivery system (SMEDDS) was developed using 32% ethyl oleate as an oil phase, 40% Tween-80 as a surfactant, and 12% Transcutol P combined with 16% PEG400 as a cosurfactant, resulting in spherical droplets with a z-average particle size of 38...
October 2, 2018: AAPS PharmSciTech
Bhaveshkumar H Kothari, Raafat Fahmy, H Gregg Claycamp, Christine M V Moore, Sharmista Chatterjee, Stephen W Hoag
The primary objective of this study was to compare two methods for establishing a design space for critical process parameters that affect ethylcellulose film coating of multiparticulate beads and assess this design space validity across manufacturing scales. While there are many factors that can affect film coating, this study will focus on the effects processing conditions have on the quality and extent of film formation, as evaluated by their impact coating yield and drug release. Ciprofloxacin HCl layered beads were utilized as an active substrate core, ethylcellulose aqueous dispersion as a controlled release polymer, and triethyl citrate as a plasticizer...
October 2, 2018: AAPS PharmSciTech
Shengjun Zhu, Mingjin Dou, Guihua Huang
To reduce the toxic and side effects of intravenous chemotherapeutic drugs on the tumor-patients, the aims of this study were to design and study intratumor-administrated irinotecan-loaded PLGA microspheres (CPT-11-PLGA-MS) in vitro and in vivo according to the structure characteristics of CPT-11. PLGA microspheres containing irinotecan were prepared by emulsion solvent evaporation method and evaluated in terms of their morphology, particle size analysis, in vitro drug release, drug retention and leakage studies in vivo, and pharmacodynamics studies...
October 2, 2018: AAPS PharmSciTech
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