Production Of Active Ingredients Research Articles

Lonza to make cancer drug for Allarity

The pharmaceutical services firm Lonza has agreed to manufacture dovitinib, an investigational pan-tyrosine kinase inhibitor for metastatic renal cell carcinoma, for the Danish biotech firm Allarity Therapeutics. Under the contract, active ingredient production and particle reduction by micronization will take place at Lonza’s facility in Visp, Switzerland. Lonza will make the finished drug in Tampa, Florida. Novartis licensed dovitinib to Allarity in 2018 after disappointing trials as a kidney cancer drug.

Green synthesis, characterization, antimicrobial and antioxidant activities of zinc oxide nanoparticles using Helichrysum arenarium extract

Active substance production at the nano-level attracts attention in the scientific world due to its wide application area. Different methods are used for the biosynthesis of nanoparticles. Recent studies have focused on non-toxic, environmentally friendly synthesis methods. Nanoparticles obtained by green synthesis using various biological elements such as plants, microorganisms and proteins have taken part in many scientific studies. Plants, which have an important potential in active ingredient production, are highly preferred in nanoparticle production. Scanning Electron Microscope and Energy Dispersive X-Ray Analysis (SEM / SEM-EDX), Fourier Transform Infrared Spectroscopy (FT-IR), X-Ray Diffraction (XRD) and Ultraviolet visible light absorption Spectroscopy (UV-vis) techniques were used for the structural and morphological characterization of Zn nanoparticles obtained by green synthesis using Helichrysum arenarium plant extract and ZnO.The antioxidant capacity of Zn NPs/Ha structures was determined by performing the DPPH test. Antimicrobial effects of zinc nanoparticles on six different pathogens (Bacillus cereus ATCC 10876, Escherichia coli ATCC 25952, Bacillus subtilis ATCC 6633, Staphylococcus aureus ATTC 29213, Pseudomonas aeruginosa ATCC 27853 and Candida albicans ATTC 90028) were investigated. As a result of this studies, it has been observed that it has an inhibitory effect against some pathogen microorganisms. It has also been found that its antioxidant content is at a significant level.

Effects of Native Arbuscular Mycorrhizae Isolated on Root Biomass and Secondary Metabolites of Salvia miltiorrhiza Bge.

Arbuscular mycorrhiza fungi (AMFs) are a group of soil-dwelling fungi that form symbiotic associations with plants, to mediate the secondary metabolism and production of active ingredients in aromatic and medicinal plants. Currently, there is little research on Salvia miltiorrhiza Bge. inoculation with native AMFs and the concomitant effects on growth and secondary metabolites. In this study, S. miltiorrhiza was treated with eight AMFs, i.e., Glomus formosanum; Gl. tenebrosum; Septoglomus constrictum; Funneliformis geosporum; Rhizophagus manihotis; Ambispora gerdemanii; Acaulospora laevis; Ac. tuberculata, to investigate the influence of AMF inoculation on biomass and secondary production under greenhouse conditions in S. miltiorrhiza roots. The results showed that mycorrhiza formation rates were between 54.83 and 86.10%. Apart from Ac. laevis and Gl. tenebrosum treatment, the roots biomass of the other treatment groups was effectively increased, and the fresh and dry weight of the plant inoculated with Fu. geosporum were increased by 86.76 and 86.95%, respectively. Specifically, AMF treatments also impacted on phenolic acids production; inoculation with both Fu. geosporum or Ac. laevis significantly reduced total phenolic acids, whereas the other treatments effectively increased these levels, of which Gl. formosanum generated significant levels. Most AMF-plant symbiotic experiments facilitated phenolic acid accumulation in the secondary metabolites of S. miltiorrhiza (except Ac. laevis). This study showed that most native AMFs inoculation with S. miltiorrhiza promoted roots growth and increased secondary metabolites production (especially phenolic acids). Going forward, inoculation of native AMF is a promising method to improve the quality and yield of S. miltiorrhiza and should be considered during production.

Research progress in molecular pharmacognosy of Pogostemon cablin

Molecular pharmacognosy( MP) is a new interdisciplinary science,which integrates the pharmacognosy and molecular biology,and focuses on the crude drugs' classification and identification,cultivation and protection,and production of active ingredients at the molecular level. Pogostemon cablin is one of the ten major southern medicines in China,MP research on this famous herb has developed on the basis of traditional research methods,and achieved certain results. This article summarized the MP research achievements of P. cablin in recent years,the prospect of this field is also discussed to provide references for the protection,development and utilization of P. cablin resources.

Voda za farmaceutsku upotrebu - značaj, vrste i zahtevi za kvalitet

Owing to its safety, wide distribution, and unique physicochemical properties, water is indispensable in pharmaceutical industry as excipient, solvent for extraction, production of active ingredients and analytical reagents, cleaning and heat-transfer agent. Various water types are used for production of pharmaceutical preparations and the water quality requirements depend on characteristics and use of final pharmaceutical preparation and production stage at which is water used. This paper summarizes regulatory requirements related to water for pharmaceutical use and systems for water production, storage and distribution in pharmaceutical industry, with focus on current regulation changes in this field. An overview on types of water for pharmaceutical use is provided, especially that official in the European and the United States Pharmacopoeia, including their quality requirements, usage and production methods.

Influence of arbuscular mycorrhizae on plant growth, essential oil production and phosphorus uptake of Salvia officinalis L.

Arbuscular mycorrhiza fungi (AMF) contribute to the secondary metabolism and production of active ingredients in aromatic and medicinal plants. This symbiotic association is particularly affected by the availability of phosphorus (P) in the soil. This study was conducted on Salvia officinalis L. using two inocula, commercial Symbivit and Septoglomus viscosum (syn. Glomus viscosum), alone or supplemented with two doses of actual P (0.03, 0.06gkg−1). The effects of these fungi and their combinations with P were determined in relation to the growth of sage plants (Regula variety), to the concentration of P in leaf tissues, and to the quantity and quality of essential oils (EOs). S. viscosum treated plants showed better growth with or without P-supply compared to non-mycorrhizal plants. The plants inoculated with S. viscosum presented the highest dry weight regardless of addition of P. Both AM fungi increased the leaf P content as more P was applied to the soil, whereas the EO content did not change with any of the treatments. Although the EO yield slightly increased with the Symbivit treatment, the chemical composition of the oil was drastically altered by S. viscosum in which the manool was the main component (28.13%), while α-thujone decreased (13.09%). These results suggest that AM symbiosis is a good candidate for promoting plant growth and essential oil composition and for improving P uptake in low fertility soils. Thus, mycorrhiza can be considered as a sustainable strategy based on natural resources in order to influence the manool and α-thujone content in sage EO composition. These compositions are very important to develop new classes of biocides and contribute to reducing risks to both human health and the environment.

Drug manufacturing woes grow

Several companies are trying to overcome manufacturing roadblocks that stopped their new drugs from being approved by FDA in 2016. In responses to their applications, FDA cited problems found during preapproval plant inspections. Most problems were in Western facilities and centered on formulation, rather than active ingredient production. Only two companies—AstraZeneca and Opko Health—responded to the problems in time to refile in 2016. And Opko got an approval after its manufacturing partner, Catalent, fixed problems at its St. Petersburg, Fla., extended-release capsule plant. Ocular Therapeutix expects to refile this quarter, while Roche’s review is delayed until late March. Meanwhile, Sanofi and Regeneron Pharmaceuticals face a major setback for the potential blockbuster drug sarilumab, a monoclonal antibody targeting the interleukin-6 receptor. If approved, it will compete in the rheumatoid arthritis field against Abbvie’s Humira, the industry’s top-selling drug. During an October earnings call, Sanofi CEO Olivier Brandicourt said the company was

RETRACTEDARTICLE: Influence of Agrobacterium rhizogenes strains, acitosyringone, inoculum size and temperature on production of active ingredients from Picrorhiza kurrooa.

RETRACTEDARTICLE: Influence of Agrobacterium rhizogenes strains, acitosyringone, inoculum size and temperature on production of active ingredients from Picrorhiza kurrooa.

Tissue culture study of the medicinal plant leek (Allium ampeloprasum L.)

Persian shallot, also called leek (Allium ampeloprasum), is a monocotyledon plant of the lily family (Liliaceae). It belongs to the genus Allium, has a characteristic taste and morphological features, making it to be considered as one of the popular herbal medicine. This research was conducted with the purpose of obtaining optimal conditions for tissue culture of Persian shallot and comparing its active ingredient production in vitro versus in vivo. In this study, the auxin 2, 4-D and benzyl aminopurine- 6 (BAP) hormones, each at two concentrations (0.5 and 0.1 mg/ L) and Kin at 0.5 mg/ L were used in the format of a randomized complete block design in three replications. Results showed that the best culture media for callus formation for leaf and seed explants were the MS cultures with the hormonal compositions (0.5 mg/ L of 2, 4- D, 0.1 mg/ L of BAP) and (0.5 mg/ L of Kin and 0.1 mg/ L of 2, 4- D). Identification of the chemical composition of the essential oils, extracted either from leek callus or leaf was carried out using GC mass analysis. Twenty one compounds were detected in the GC mass spectra, seven of which constitutv about 51.5% of the total amount of compounds present in the essential oils were identified. Our data demonstrate that the leek essential oil constituents as well as callus formation can be affected by culture medium condition.

Fixed Combination Drugs for Cardiovascular Disease Risk Reduction: Regulatory Approach

The use of combination drug therapy for cardiovascular (CV) disease risk reduction is the established approach to multiple risk factor reduction. The spectrum of rational combination products in CV disease prevention and treatment alone is extremely broad. Development of fixed-dose combination drug products requires information beyond that needed for approval of single active ingredient products. Establishing the rationale and target populations for novel combinations, as well as the contributions of the component drugs to the claimed effects, and characterizing the pharmacokinetics, the pharmacodynamics, and clinical safety and efficacy of the combination are all necessary to support approval.

Plant co-ordination in pharmaceutics supply networks

The production of active ingredients in the chemical-pharmaceutical industry involves numerous production stages with cumulative lead times of up to two years. Mainly because of rigorous purity requirements and the need of extensive cleaning of the equipment units, production is carried out in campaigns, i.e. multiple batches of the same product type are produced successively before changing to another product type. Each campaign requires a specific configuration of equipment units according to the recipes of the particular chemical process. In the chemical-pharmaceutical industry, production stages are often assigned to different locations, even different countries. Hence the co-ordination of plant operations within the resulting multi-national supply network is of major importance. A key issue is the co-ordination of campaign schedules at different production stages in the various plants. In practice, it is almost impossible to determine exact optimal solutions to the corresponding complex supply network problem with respect to overall logistics costs. In order to reduce the required computational effort, we introduce several aggregation schemes and a novel MILP model formulation which is based on a continuous representation of time. Moreover, we propose an iterative near-optimal solution procedure which can be successfully applied to even exceptionally large real life problem instances. The applicability of the approach suggested is shown using a case study from industry.

Plasma-derived products: therapeutic biological products

The status of proprietary medicinal product has been conferred upon plasma derived products (PDP) by the European Community in its directive issued on the 14 of June 1989. This directive requires each Member State to comply with the current regulations applicable to medicinal products related to production, control and registration of PDP. A different evolution characterized the American regulation in which PDP have been classified as biological products, submitted to a particular regulation since 1992. These different conceptions led the authors to systematically review the specificities of PDP in comparison to classical medicinal products: plasmatic raw material, production of active ingredients and manufacturing of products in the same facility, divergent production of several products from a single starting material, infection risks and variability characterizing biological products, registration and distribution. The analysis of complementary regulation issued to adapt the pharmaceutical principles to the PDP shows that it does not provide all the expected answers to the specificities of the PDP. This shows the advantages that could be expected by giving a status of biological therapeutic product to the PDP. This could above all allow to federate qualified people and data in order to take into account more accurate and more immediate information about risks which may arise in very dispersed fields. This could also serve as a reminder of the ethical principles attached to the preparation of products coming from a human source.