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Drug Development and Industrial Pharmacy

Bindhu Madhavi Rayaprolu, Jonathan J Strawser, Gopal Anyarambhatla
Excipients form a major component of pharmaceutical formulations and are classified as any ingredient other than the active ingredient which is included within the product formulation to improve drug product performance. Functional uses of excipients include improving solubility and stability, safety and efficacy, as bulking agents in lyophilized formulations, tonicity agents, and aiding in controlled or prolonged drug delivery. Parenteral formulations are sterile, pyrogen-free; free of particulate matter and by-pass the body's natural defense mechanisms...
July 13, 2018: Drug Development and Industrial Pharmacy
Ujjawal Bairagi, Pooja Mittal, Juhi Singh, Brahmeshwar Mishra
Diabetes mellitus is most common disorder characterize by hyperglycemia. Chronic hyperglycemia may lead to over production of free radicals thereby results in oxidative stress which impaired healing of wounds. Ferulic acid (FA) has been shown to have antidiabetic and antioxidant properties. The aim of the present study was to develop Ferulic acid nanoparticles and to study its hypoglycemic and wound healing activities. Ferulic acid- poly (lactic-co-glycolic acid) (FA-PLGA) nanoparticles were prepared by nano precipitation method...
July 5, 2018: Drug Development and Industrial Pharmacy
Gehan Fathy Balata, Hanan Abd El-Moneom Shamardl, Hanan Mohamed Abd Elmoneim, Afnan Abdullah Hakami, Maeen Abdulaziz Almodhwahi
OBJECTIVES: To develop an alternative medicine, propolis, in emulgel formulation for burn and wound treatment. METHODS: The effect of two independent variables: emulsifying agent concentration and oil concentration on the cumulative amount of propolis release (dependent variable) from liquid paraffin and isopropyl palmitate emulgels was investigated. Eight formulations were prepared and evaluated for physical appearance, pH, propolis content, viscosity and in vitro propolis release...
July 5, 2018: Drug Development and Industrial Pharmacy
Basant A Abou-Taleb, Mohamed Ismail Nounou, Nawal Khalafallah, Saleh Khalil
Controversies surround levothyroxine sodium as a drug and product, and are reflected in compendia (USP vs BP) differences in levothyroxine sodium tablets specifications concerning potency limit and dissolution test conditions, and in lack of consensus on several issues such as whether the drug BCS class I or III. We have recently published a clinical study in patients comparing the efficacy of multisource 100 mcg levothyroxine sodium tablets (three sources, two brands, a total of five batches) [1]. Clinical efficacy and dissolution rate data varied among the tablets batches studied and indicated that brand/source interchangeability could not be claimed...
July 5, 2018: Drug Development and Industrial Pharmacy
Hamed Nosrati, Marziyeh Salehiabar, Hamidreza Kheiri Manjili, Soodabeh Davaran, Hossein Danafar
In this work, we reported the synthesis of curcumin (CUR)-loaded hydrophilic and hydrophobic natural amino acids (AAs)-modified iron oxide magnetic nanoparticles (IONPs). Two types of AAs, l-lysine (Lys) and l-phenylalanine (PhA), were selected to study their effects on loading capacity, release profile of CUR, biocompatibility, and anticancer activity. CUR-loaded AAs-modified IONPs (F@AAs@CUR NPs) were characterized by X-ray diffraction (XRD), thermogravimetric analysis (TGA), Fourier transform infrared spectroscopy (FTIR), vibrating sample magnetometer (VSM), and transmission electron microscopy (TEM) techniques...
July 4, 2018: Drug Development and Industrial Pharmacy
Maha Fadel, Kawser Kassab, Doaa A Abd El Fadeel, Maha Nasr, Nayera Mohamed El Ghoubary
Curcumin is a natural pigment that generates singlet oxygen upon light excitation, hence it can be used as a photosensitizer in photodynamic therapy. The extremely low water solubility and poor systemic bioavailability make curcumin a challenging molecule to be used clinically. In the current manuscript, two nanocarrier systems for curcumin were prepared and characterized; nanoliposomes and PVP capped gold nanoparticles. The dark and photocytotoxicity were investigated as a function of light fluence rate (100 and 200 mW/cm2 ) on HepG2 cancer cells...
July 3, 2018: Drug Development and Industrial Pharmacy
Mehtap Saydam, Sevgi Takka
The main objective of the present study was the development of pH-independent controlled release valsartan matrix tablet in Quality by design (QbD) framework. The quality target product profile (QTPP), critical quality attributes (CQAs)and critical material attributes (CMAs) were defined by science and risk-based methodologies. Potential risk factors were identified with Fishbone diagram. Following, CMAs were further investigated with a semi-quantitative risk assessment method, which has been revised with mitigated risks after development and optimization studies...
July 3, 2018: Drug Development and Industrial Pharmacy
Peter Grdešič, Tamás Sovány, Ilija German Ilić
CONTEXT: Knowledge of the effects of high-shear granulation process parameters and scale-up on the properties of the produced granules is essential for formulators who face challenges regarding poor flow and compaction during development of modified release tablets based on high-molecular weight hypromellose (HPMC) polymers. Almost none of the existing studies deal with realistic industrial formulation. OBJECTIVE: The aim was to investigate the effects of scale-up and critical process parameters (CPPs) of high-shear granulation on the quality attributes of the granules, particularly in terms of the flow and compaction, using a realistic industrial formulation based on HPMC K100M polymer...
July 3, 2018: Drug Development and Industrial Pharmacy
Sumathi Rajamani, Arun Radhakrishnan, Tamizharasi Sengodan, Sivakumar Thangavelu
Naringenin (NAR) is a naturally occurring plant flavonoid, found predominantly in citrus fruits, possesses a wide range of pharmacological properties. However, despite the therapeutic potential of NAR, its clinical development has been hindered due to low aqueous solubility and inefficient transport across biological membranes resulting in low bioavailability at tumor sites. In our previous studies, nanosuspension of naringenin (NARNS) was prepared using high pressure homogenization method using different polymers...
July 3, 2018: Drug Development and Industrial Pharmacy
Mohammad Mahmoudian, Hadi Valizadeh, Parvin Zakeri-Milani
Bortezomib (BTZ), a proteasome inhibitor, is clinically used for the treatment of multiple myeloma and mantle cell lymphoma via intravenous or subcutaneous administration. Since BTZ has limited intestinal permeability, in this study, solid lipid nanoparticles (SLNs) were selected as lipid carrier to improve the intestinal permeability of BTZ. The nanoparticles were prepared by hot oil-in-water emulsification method and characterized for physicochemical properties. Moreover, in situ single-pass intestinal perfusion technique was used for intestinal permeability studies...
July 2, 2018: Drug Development and Industrial Pharmacy
P Gieszinger, I Tomuta, T Casian, Cs Bartos, P Szabó-Révész, R Ambrus
OBJECTIVE: Design of Experiment (DoE), that is a tool of Quality by Design (QbD) paradigm, with which experiments can be planned more effectively and provide more information, while after Design Space (DS) can be set up, which assure the quality of the desired product. The aim of this study was to find the optimal drug-excipient ratio and the optimal process parameters (milling time, milling speed) of our previously used dry co-milling method and validate the DS. MATERIALS AND METHODS: Lamotrigine (LAM), an antiepileptic drug was used as a model API...
July 2, 2018: Drug Development and Industrial Pharmacy
Meiyue Shen, Chao Liu, Xiaocao Wan, Nabil Farah, Liang Fang
OBJECTIVE: The aim of this study was to develop a drug-in-adhesive patch for transdermal delivery of daphnetin (DA), which is a coumarin derivative in Girald Daphne, and to investigate the role of Transcutol P (TP) in the release and percutaneous permeation processes of DA. METHODS: Backing films, permeation enhancers and enhancer content in the transdermal patch were investigated through in vitro experiments using rat skin. Anti-inflammatory and analgesic effects of the optimized formulation were evaluated using the adjuvant arthritis model and the pain model induced by acetic acid, respectively...
July 2, 2018: Drug Development and Industrial Pharmacy
Bharat Kumar Reddy Sanapalli, Elango Kannan, Shivaramakrishnan Balasubramanian, Jawahar Natarajan, Uday Krishna Baruah, Veera Venkata Satyanarayana Reddy Karri
5-Aminosalicylic acid (5-ASA) is an aminosalicylate anti-inflammatory drug, which is also known as mesalazine or mesalamine. Currently employed in treating inflammatory bowel disease, ulcerative colitis, inflamed anus or rectum, and maintain remission in Crohn's disease. Evidence from the researchers highlighted its significant re-epithelization in allergic asthma, aphthous, and gastric ulcerative conditions. The objective of the study was to formulate the pluronic lecithin organogel (PLO) containing 5-ASA and evaluate its wound-healing ability in a full thickness excision wound rat model...
July 2, 2018: Drug Development and Industrial Pharmacy
Aaron Eskinazi-Budge, Dharani Manickavasagam, Tori Czech, Kimberly Novak, James Kunzler, Moses O Oyewumi
Simvastatin (Sim) is a widely known drug in the treatment of hyperlipidemia, which has attracted so much attention in bone regeneration due to its potential osteoanabolic effect. However, repurposing of Sim in bone regeneration will require suitable delivery systems that can negate undesirable off-target/side effects. In this study, we have investigated a new lipid nanoparticle (NP) platform that was fabricated using a binary blend of emulsifying wax (Ewax) and glyceryl monooleate (GMO). Using the binary matrix materials, NPs loaded with Sim (0-500 µg/mL) were prepared and showed an average particle size of about 150 nm...
July 2, 2018: Drug Development and Industrial Pharmacy
Elvilene de Sousa Coêlho, Gláucia Laís Nunes Lopes, Iluska Martins Pinheiro, Josefa Natália Policarpo de Holanda, Michel Muálem de Moraes Alves, Naiane Carvalho Nogueira, Fernando Aécio de Amorim Carvalho, André Luis Menezes Carvalho
OBJECTIVE: This work aimed to develop and characterise a topical emulgel of amphotericin B (AmB) with bacuri butter (Platonia insignis Mart.) and evaluate its antileishmanial activity using in vitro assays. SIGNIFICANCE: Leishmaniasis is considered an infectious disease, with high incidence and capacity to produce deformities. The first-line treatment recommended by WHO, with pentavalent antimonials, is aggressive and very toxic. Therefore, the development of topical treatments can emerge as a promising and less offensive alternative...
June 30, 2018: Drug Development and Industrial Pharmacy
K P Dühlmeyer, H Özcoban, C S Leopold
OBJECTIVE: The aim of this study was to investigate whether the filling level within the feed frame of a rotary tablet press can be quantified by laser triangulation combined with the angle recognition of one paddle wheel via rotary encoder. SIGNIFICANCE: Rotary tablet press feed frames are supposed to assure a uniform die filling and thus to guarantee the weight and content uniformity of the resulting tablets. Therefore, a constant bulk availability and flow within the feed frame is crucial and has to be ensured by the feed frame design and the operating conditions...
June 30, 2018: Drug Development and Industrial Pharmacy
Kira-Isabel Zier, Wulf Schultze, Claudia S Leopold
OBJECTIVE: The objective of this study was to characterize properties of aqueous Sennae fructus extracts prepared by spray-drying at varying process conditions. SIGNIFICANCE: From an industrial point of view it is essential to develop a formulation which has a constant quality over the whole period of its specified shelf-life. METHOD: Sennae fructus extracts were spray-dried with different atomizing gas pressures, pump feed rates, and inlet temperatures...
June 29, 2018: Drug Development and Industrial Pharmacy
Ahmed A H Abdellatif, Hesham M Tawfeek
OBJECTIVE: It is difficult to identify the gold nanoparticles (AuNPs) intracellularly due to their non-fluorescent nature. Although gold can quench the fluorescence of any fluorophore, hence it is also difficult to combine gold with a fluorophore such as a semiconductor quantum dots (QDs). The aim of this study was to prepare a single fluorescent stable AuNPs combined with QDs (QDs-Au-NPs) which can be easily detected intracellularly. METHODS: QDs-Au-NPs were prepared via a simple one-step process through controlling the spacing between them using polyethylene glycol (PEG) as space linker in the form of PEGylated QDs...
June 25, 2018: Drug Development and Industrial Pharmacy
Vandita Kakkar, Indu Pal Kaur, Amrit Pal Kaur, Komal Saini, Kamalinder K Singh
Tetrahydrocurcumin (THC) also referred to as "white curcumin", is a stable colourless hydrogenated product of curcumin with superior antioxidant and anti-inflammatory properties. Present study is an attempt to elevate the topical bioavailability of THC, post incorporation into a nano-carrier system with its final dosage as a hydrogel. Lipid nanoparticles of THC (THC-SLNs) prepared by microemulsification technique were ellipsoidal in shape (revealed in TEM) with a mean particle size of 96.6 nm and zeta potential of -22 mV...
June 25, 2018: Drug Development and Industrial Pharmacy
Yi Zhang, Bing Xu, Xin Wang, Shengyun Dai, Fei Sun, Qun Ma, Xinyuan Shi, Yanjiang Qiao
The purpose of this study was to describe the raw material variability that influenced the in-vitro dissolution behavior of high drug-load sustained-release matrix tablet and to ensure the consistent quality of the final product. The Panax notoginseng saponins (PNS) - hydroxypropyl methylcellulose - anhydrous lactose - magnesium stearate (57:20:23:0.5%, w/w) was used as the model formulation. PNS extract powders with lot-to-lot and source-to-source differences were collected to cover the common cause variations and their physicochemical properties were characterized by the chromatographic fingerprints and the SeDeM expert system...
June 25, 2018: Drug Development and Industrial Pharmacy
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