Nanotechnology-based cosmetic preparations have a wide scope for herbal cosmetics also in the near future.
Throughout the most recent couple of years, countless evidence has developed, demonstrating that chemically differentclasses of naturally occurring substances are potent in the treatment of several dermatological disorders caused by UV radiation exposure. Flavonoids, terpenes, polyphenols, alkaloids, and catechins are chemical classes that have been focused for photochemopreventive property and resveratrol, curcumin, quercetin and caffeic acid are a couple of examples of such compounds. These antioxidants have been suggested as a beneficial strategy for diminishing the UV-radiation intervened oxidative harm to the skin. For instance, the topical application or oral administration of plant concentrates, for example, black and green tea, A. vera, coffee, apricot, coconut oil, cucumber, and quercetin is speculated to be defensive against premature aging, UV-initiated erythema and radiation prompted tumor.
The fundamental part for being able to utilize printed APIs for cleaning validation purposes, is the printed amount of API per area. In this work, three methods were used for adjusting the theophylline amount per area and one showed more potential than the others. The optimized ink composition containing 5.8 mg/mL theophylline was successfully printed on all substrates in five different concentrations per area (0.59, 2.34, 4.78, 58.12, 118.60 µg/cm 2 ) by adjusting the drop spacing. This was presented to be the most suitable method for adjusting the printed API concentration per area for this work. The printed theophylline dose per area was also increased drastically by printing several layers of ink with the highest API dose, 118.60 µg/cm 2 , on each other. Since the layers where dried in a vacuum oven over night, before the next layer was printed on top of the previous one, this method was rather time consuming and could only be recommended for printing high doses of API per area, when the maximum API loading in the ink, limited to the solubility of the API, is exceeded.
e.g., seeking thermochemical safety, scaling-up, achieving the desired physicochemical attributes of the bulk drug, captur- ing and applying the process know-how.
As of this writing in 2004, the process development milieu of the bulk drug industry is quite varied—from the large drug company in which all the skills are represented to the small virtual firm that contracts out the work, as well as firms that do selected process development tasks as part of their attempt to secure the eventual manufacturing busi- ness from the owner of the drug candidate. The author has not attempted to deal separately with these different environ- ments lest the exposition of the target fundamentals get obscured by the specifics of each case. Instead, the bulk drug process development task is discussed within the continuum of a large drug company and commentary that applies to other contexts has been inserted, hopefully in a sparing and incisive manner.
The APIC/CEFIC Conference on Active Pharmaceutical Ingredi- ents is Europe’s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Confer- ence. Speakers from FDA, EMA, EDQM, National Authorities, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance. The GMP Conference, of which the final part is a Joint GMP & RA session, provides updates from recent authorities’ initiati- ves, activities and interpretations related to GMP compliance of API manufacturing. Hear from industry speakers their ap- proaches and best practices on compliance related to the vari- ous existing and emerging aspects of API GMP.
An exploration of seemingly contradictory flavours, and the ability that animals – here, bees and oysters – have to transform elements from their environment into a unique physical form. An expression of biodiversity, of humble ingredients that were often elevated to the heights of luxury Taster
The criteria of "suitability" does not necessarily mean meeting the original specifica- tion, (as is discussed in § 14.41 above).
14.43 The documentation required here can, in most cases, only be of a general nature, unless the quantity of recovered solvents per batch can be measured. This is very rarely the case when solvents are continuously recovered in a campaign or in continu- ous production. In such cases it may only be possible to record how much new sol- vent is being added in what period of time to make up for losses caused by the recov- ery process. It is not expected that records more detailed than those required to for economic purposes such as a record of the overall use of materials should be retained. However the record should indicate whether the solvent had been recovered from the same or from a different process, to help in identifying unknown impurities if these start increasing during the production campaign.
In addition to crystal structure prediction, one of the challenges of organic crystal engineering is the ability to synthesise higher order crystals. In order to synthesise ternary or higher order co-crystals, a better understanding of the molecular recognition processes is required.
Synthesizing higher order co-crystals and understanding molecular recognition processes is absolutely essential if we are to understand the enormously complex and efficient molecular recognition processes in enzyme–coenzyme–substrate complexes. 177 While the number of binary co-crystals are increasing every day, synthesis of ternary or higher order crystals is still challenging and frustrating, with few exceptions. 178 This is largely due to the absence of reliable structural paradigms. Synthesis of ternary or higher order co-crystals is also hampered by the number of possible cross-over reactions and by the solubility of the components. A mixture of several components with quite different solubility profiles could form a co-crystal, but more often than not will only result in the precipitation of the individual component with the lowest solubility. One alternative for this is to select the solvent of crystallisation as one of the components, which has been followed in the work presented here. While there is no agreement between different research groups on what constitutes a component, it is accepted that if there is a crystal engineering aspect attached to how the solvent molecules arrange within the crystal then the solvent molecule can be regarded as a component and the molecular complex termed as ternary or binary co-crystal rather than a co-crystal solvate or solvate.
Gossypin, a pentahydroxy flavone glucoside found rich in the flowers of Hibiscus vitifolius, possess many biological properties including antidiabetic, anti- oxidant, anti-inflammatory and anticancer. Oral administration of gossypin to diabetic rats normalized the levels of plasma protein and blood urea. The obtained data were comparable with gliclazide, a standard reference drug for diabetes. Hence, it was concluded that gossypin has potent antidiabetic activity in streptozotocin-induced experimental diabetes in rats. Petroleum ether and ethyl acetate fractions of the leaves of Coccinia cordifolia have potential antidiabetic activity 60-61 . Most of the active compounds isolated from the antidiabetic plants are secondary metabolites. These hypoglycemic constituents include alkaloids, flavonoids, triterpenoid s, polysaccharides, glycopeptides, aminobutyric acid derivatives, steroids, iridoids, phenolics, peptides, alkyldisulfides and inorganic ions 62 .
The main controlling factors in the crystallization of polymorphs include temperature, supersaturation, and type of solvent, as well as the addition of seed crystals, stirring rate, and interfaces. It is well-known that in enantiotropic systems, the thermodynamic stability order among polymorphs can be inverted by shifting temperature above and below the transition temperature. Moreover, the temperature can change the dissolution rate, and the kinetics of nucleation and growth of each polymorph retarding the appearance of certain polymorphs and promoting others. Also, it has been shown that a rapid generation of supersaturation provides crystals of different polymorphic forms when compared with those obtained with a slow increase in supersaturation 13 . In the case of the effect of solvents, the interactions between solute and solvent molecules result in solute molecules assembling in particular conformation structure and/or packing mode.
The search for evidence in investigations to justify the permanency and broad diffusion of lectures as a pedagogical strategy is useless. Most papers arising from classroom observations and personal experi- ences suggest new strategies to revitalize classes, making them more active for students. This attitude towards lectures reveals the need experienced educa- tors feel to introduce changes when it comes to teach- ing strategies. However, there are arguments in favor of lectures: some people believe that professors add a motivating and formative value to each class and that they act as a figure of identification; others argue that attending classes can foster a sense of discipline in the student, who is obliged to follow a schedule; others say it can promote multiple forms of social interac- tion, or that its content can communicate knowledge that is a product of recent investigations that have not been published yet, or that some classes are very well conceived by educators who have a special taste for their design and who have a special ability to commu- nicate and, therefore, are very popular among stu- dents. There are also those who consider that present- ing a good oral argument is a very valuable form of academic speech (15, 16) .
Use 1 1/2 fl. oz. in 1 quart of water, treating 400 linear feet with a 6-inch spray band.
OUTSIDE SURFACES OF BUILDING
Use this product on Ants, Clover mites, Crickets, Earwigs, Millipedes, Sowbugs (Pillbugs) and spiders to help prevent infestation of buildings, treat the building foundation to a height of 2 to 3 feet, where pests are active and may find entrance. Also, apply as a residual spray but not to the point of runoff to outside surfaces of building, including porches, screens, window frames, eaves, patios, garages, refuse dumps and other areas where these pests congregate or have been seen.
N U S A G E - P h a r m E n g 2 0 1 2 P r o f e s s i o n a l T r a i n i n g P r o g r a m
I C H Q 7 – G M P f o r A c t i v e P h a r m a c e u t i c a l I n g r e d i e n t s
ICH Q7 standards are used by all Active Pharmaceutical Ingredients (API) manufacturers operating in regulated markets to implement Good Manufacturing Practices (GMP). This course is specially designed to enable participants realize the benefits of GMP and ICH Q7 guidelines . Practical implementation of GMP concepts on critical aspects of the pharmaceutical and biotechnology operations will be addressed, as well as the latest updates on GMP and validation requirements.
CHAPTER ONE Introduction
Chemistry is an evolving subject and it is traditionally divided into four categories as organic, inorganic, physical and analytical chemistry. A new classification in the modern era is the (supramolecular) solid state chemistry which is different from the molecular chemistry (liquids and gases). It has now reached the immense importance in the level of identification, separation and characterization of different crystalline forms of the same molecule or of aggregates of molecules with other molecules due to the difference in their physical and chemical properties. Physical properties are an intrinsic part of solid state chemistry since the broad area of structure-property relationship needs the identification of new solid crystalline forms such as polymorphs, solvates/hydrates, salts and cocrystals (Figure 1) and their characterization to understand their properties to control their activity. The importance of identifying these crystalline materials is to investigate their physico-chemical issues of active pharmaceutical ingredients (APIs) and address the solubility, stability and hydration problems using the crystal engineering approach. Crystal engineering of APIs through cocrystallization has gained an immense interest among the academicians, pharmaceutical scientists and US-FDA regulating as means of optimizing the physical properties and/or stability of solid dosage forms.
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Vegetable oils are obtained by mechanical extraction or cold pressing of various parts of plants, most often: seeds, fruits, and drupels. Chemically, these oils are compounds of the ester-linked glycerol and higher fatty acids with long aliphatic chain hydrocarbons (min. C14:0). Vegetable oils have a variety of properties, depending on their percentage of saturation. This article describes sea-buckthorn oil, which is extracted from the well characterized fruit and seeds of sea buckthorn. The plant has a large number of activeingredients the properties of which are successfully used in the cosmetic industry and in medicine. Valuable substances contained in sea-buckthorn oil play an important role in the proper functioning of the human body and give skin a beautiful and healthy appearance. A balanced composition of fatty acids give the number of vitamins or their range in this oil and explains its frequent use in cosmetic products for the care of dry, flaky or rapidly aging skin. Moreover, its unique unsaturated fatty acids, such as palmitooleic acid (omega-7) and gamma-linolenic acid (omega-6), give sea-buckthorn oil skin regeneration and repair properties. Sea-buckthorn oil also improves blood circulation, facilitates oxygenation of the skin, removes excess toxins from the body and easily penetrates through the epidermis. Because inside the skin the gamma-linolenic acid is converted to prostaglandins, sea-buckthorn oil protects against infections, prevents allergies, eliminates inflammation and inhibits the aging process. With close to 200 properties, sea-buckthorn oil is a valuable addition to health and beauty products.
As mentioned above, numerous investigations are pub- lished about the in vitro and in vivo pharmacological effects and mechanisms of GBE and its components. The extensive knowledge about the pharmacokinetic charac- teristics including absorption, excretion and metabolism of the pharmacodynamic active compounds, the TTL and the flavonoids of Ginkgo biloba, allows an evaluation and discussion of the pharmacological mechanisms. In 1986, Moreau et al. studied the absorption of a radiolabelled 14 C extract prepared from Ginkgo biloba leaves in rats. The pharmacokinetics of radiolabelled EGb 761 Ò was charac- teristic for a two-compartment model, with an apparent first-order phase and a half-life of about 4–5 h. Absorption was at least 60 % and specific activity in blood peaked after 1–5 h. At 3 h, the highest values for specific radio- activity were measured in the stomach and small intestine, indicating that this may be the site of absorption. Glandular and neuronal tissues and eyes showed a high affinity for the labelled substance. After oral administration, exhaled
Our results confirm the alteration of antioxidant enzyme activities in mussels’ gills during a short-term exposure to 250 ng.L −1 of NSAID IBU, particularly evident by the enhancement of SOD activities over the first week and GR activity overall inhibition in exposed mussels. In order to better interpret an alteration of the antioxidant defense system caused by biologically active contaminants, two aspects have to be taken into account, (1) APIs therapeutic properties are based on redox reactivity and oxidative stability (Harmon et al., 2006; Martín-Díaz et al., 2009) and (2) NSAIDs (such as IBU) are known to disrupt eicosanoid biosynthesis (through the inhibition of COX pathway and prostaglandins) in both invertebrates and vertebrates (Heckmann et al., 2008). The blockage of one of the three membrane-phospholipid arachidonic acid (AA) metabolic pathways (beside, lipoxygenase (LOX) pathway and cytochrome P450 epoxygenase pathway) may distress several physiological functions (such as immune system, reproduction and ion transport) (Gagné et al., 2005; Rowley et al., 2005; Heckmann et al., 2008; Ericson et al., 2010). Furthermore, an increase of ROS is associated to an AA conversion via LOX pathway while the inverse effect can be found when transformed into prostaglandins via COX pathway (Ardaillou et al., 1987). Several studies refer the association of AA accumulation to an enhancement of basal ROS production, hemocytes concentration, phagocytosis and mitochondrial dysfunction either in mammals (Cocco et al., 1999) or in invertebrates (i.e. oysters fed by an AA supplemented diet) (Delaporte et al., 2006). For these reasons, we hypothesize that a possible accumulation of AA in the cells due to COX metabolic pathway obstruction may promote the increment of H 2 O 2 production and consequently be other factor contributing for cell oxidative status alteration.
mm column is used. For maximum resolution, choose a 100 mm length and for faster analysis, and higher sample throughput, choose 50 mm column.
Figure 5: Different column chemistry available for UPLC
Half- height peak widths of less than one second are obtained with 1.7μm particles, which gives significant challenges for the detector. In order to integrate an analyte peak accurately and reproducibly, the detector sampling rate must be high enough to capture enough data points across the peak. The detector cell must have minimal dispersion (volume) to preserve separation efficiency. Conceptually, the sensitivity increase for UPLC detection should be 2-3 times higher than HPLC separations, depending on the detection technique. MS detection is significantly enhanced by UPLC; increased peak concentrations with reduced chromatographic dispersion at lower flow rates promote increased source ionization efficiencies.
Companies should be aware that according to Article 46 of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the pre- vention of the entry into the legal supply chain of falsified medicinal products, have to ap- ply the following. The holder of a manufacturing authorization shall at least be obliged to use only active substances, which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good dis- tribution practices for active substances. Distributors of active substances may, according to Article 111 of the same directive, become subject to inspections by the competent au- thority.