Selection of API Vendors and the Impacts on Drug Products

2021 ◽  
pp. 13-22
Author(s):  
Erfan Syed Asif
Keyword(s):  
Drug Products ◽  
Selection Of

scholarly journals Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives

2020 ◽  
Vol 117 (27) ◽  
pp. 16009-16018 ◽  
Author(s):  
Ling Zou ◽  
Peter Spanogiannopoulos ◽  
Lindsey M. Pieper ◽  
Huan-Chieh Chien ◽  
Wenlong Cai ◽  
...  
Keyword(s):  
Drug Absorption ◽  
Azo Dye ◽  
Pharmacokinetic Studies ◽  
Unintended Effects ◽  
Drug Products ◽  
Intestinal Drug Absorption ◽  
High Concentrations ◽  
Gut Microbial Community ◽  
Selection Of

Food and drug products contain diverse and abundant small-molecule additives (excipients) with unclear impacts on human physiology, drug safety, and response. Here, we evaluate their potential impact on intestinal drug absorption. By screening 136 unique compounds for inhibition of the key intestinal transporter OATP2B1 we identified and validated 24 potent OATP2B1 inhibitors, characterized by higher molecular weight and hydrophobicity compared to poor or noninhibitors. OATP2B1 inhibitors were also enriched for dyes, including 8 azo (R−N=N−R′) dyes. Pharmacokinetic studies in mice confirmed that FD&C Red No. 40, a common azo dye excipient and a potent inhibitor of OATP2B1, decreased the plasma level of the OATP2B1 substrate fexofenadine, suggesting that FD&C Red No. 40 has the potential to block drug absorption through OATP2B1 inhibition in vivo. However, the gut microbiomes of multiple unrelated healthy individuals as well as diverse human gut bacterial isolates were capable of inactivating the identified azo dye excipients, producing metabolites that no longer inhibit OATP2B1 transport. These results support a beneficial role for the microbiome in limiting the unintended effects of food and drug additives in the intestine and provide a framework for the data-driven selection of excipients. Furthermore, the ubiquity and genetic diversity of gut bacterial azoreductases coupled to experiments in conventionally raised and gnotobiotic mice suggest that variations in gut microbial community structure may be less important to consider relative to the high concentrations of azo dyes in food products, which have the potential to saturate gut bacterial enzymatic activity.

Microscopic radiography: A combined technique for improved analytical microscopic analysis and interpretration

1996 ◽  
Vol 54 ◽  
pp. 248-249
Author(s):  
A. Angel ◽  
R.C. Moretz
Keyword(s):  
Microscopic Analysis ◽  
Device Structure ◽  
Electron Microscopic ◽  
Drug Products ◽  
Microscopic Evaluation ◽  
Final Interpretation ◽  
And Function ◽  
Non Destructive ◽  
Combined Technique ◽  
Selection Of

Microscopic analysis of pharmaceutical devices and products relies primarily on destructive sample preparative methods, including sectioning, sawing, grinding and embedding. Reconstruction of images obtained from the prepared samples is often necessary to interpret the results. The preparative methods can introduce artifacts or distortion, which can affect the analysis, and the inability to visualize the intact object can also affect the interpretation. Radiography has been used to assist in the selection of preparative methods for microscopy, determine optimal orientation during preparation and analysis and to aid in the visualization and integration of the microscopic results in the final interpretation. The application of x-ray radiography to the examination of intact devices or manufactured drug products in conjunction with standard light and scanning electron microscopic evaluation presents a novel non-destructive technique to assess device structure and function as well as locate potential inclusions in manufactured drug products.

Therapeutic Assessment of Slow-K and K-Tab Potassium Chloride Formulations in Hypertensive Patients Treated with Thiazide Diuretics

1987 ◽  
Vol 21 (5) ◽  
pp. 445-450
Author(s):  
Vasilios A. Skoutakis ◽  
Charles A. Carter ◽  
Sergio R. Acchiardo
Keyword(s):  
Potassium Chloride ◽  
Patient Acceptance ◽  
Therapeutic Assessment ◽  
Open Label ◽  
Hypertensive Patients ◽  
Drug Products ◽  
Normal Limits ◽  
Dosing Regimens ◽  
Therapeutic Equivalency ◽  
Selection Of

Therapeutic equivalency among different drug products is one of the major issues confronting many clinicians today who are functioning as members of pharmacy and therapeutic committees and state Medicaid programs (SMP). Selection of one of the available slow-release potassium chloride formulations for inclusion in a hospital formulary or SMP exemplifies one of these therapeutic equivalency issues. To evaluate this issue, we studied 20 hypertensive adult patients receiving hydrochlorothiazide 50 mg/d to determine if there are significant differences between the administration of 24 mEq of Slow-K given as 8 mEq/tablet tid, and 30 mEq of K-Tab given as a 10 mEq/tablet tid. The study was conducted in a randomized, open-label, crossover design in which the two drug formulations of potassium chloride were compared over two four-week treatment periods. Results from this study indicate that 24 mEq of Slow-K and 30 mEq of K-Tab were equally effective in maintaining serum electrolyte concentrations, blood pressure measurements, and electrocardiogram evaluations within normal limits in all 20 hypertensive patients studied. Furthermore, no adverse effects were noted with either potassium chloride formulation, and patient acceptance, tolerability, and compliance to prescribed dosing regimens were similar for both products. Based on our findings, therefore, we conclude that 24 mEq of Slow-K and 30 mEq of K-Tab given three times daily as 8 mEq and 10 mEq tablets, respectively, are therapeutically equivalent.

scholarly journals Recommendations of scientifically sound and appropriate sampling plans for parenteral drug products

2021 ◽  
Author(s):  
Ian Aled Jones ◽  
Alex Bird ◽  
Nathaniel Lochrie
Keyword(s):  
Sample Size ◽  
Key Words ◽  
Visual Inspection ◽  
Drug Product ◽  
Sample Sizes ◽  
Sampling Plans ◽  
Drug Products ◽  
Product Manufacture ◽  
Selection Of ◽  
Parenteral Drug

This paper gives recommendations for defining sampling plans/sizes that are statistically justified or based on published guidance for typical parenteral drug products Simple tables based on the ANSI/ASQ Z1.4 acceptance sample plans or other published guidance have been collated to aid organisations in selection of appropriate sample sizes/plans for routine drug product manufacture. Key Words: USP <1790>, visual inspection, AQL, power, sample size

US Food and Drug Administration Black Box Warnings

2020 ◽  
Vol 110 (1) ◽  
Author(s):  
Robert G. Smith
Keyword(s):  
Adverse Effects ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Black Box ◽  
Ethical Obligation ◽  
Drug Products ◽  
Body Of Knowledge ◽  
Drug Adverse Effects ◽  
Black Box Warnings ◽  
Selection Of

Podiatric Physicians have an ethical obligation to prescribe responsibly and cautiously to diminish and minimize the growth of drug adverse effects. Clinicians who prescribe, dispense, and administer medications must be vigilant in continually reviewing new Black Box Warnings for medications they use for their patients. The safe and appropriate selection of medications and prescribing strategies are presented. First, the concept and process for these FDA black box warnings are introduced. Then, to enrich the podiatric physician's body of knowledge, several FDA boxed warnings from 27 selected drug products that may be prescribed by podiatric physicians are presented graphically as a table. Finally, strategies for safe prescribing of these drugs with boxed warnings are presented.

scholarly journals A review on analytical method development, optimization and validation of combination of Azithromycin and benzoyl peroxide by RP-HPLC using design of experiment as per ICH guideline

2018 ◽  
Vol 6 (02) ◽  
pp. 53-63
Author(s):  
Narendra Singh ◽  
Yogendra Singh ◽  
R. S. Bhadauria ◽  
Jeyabalan Govindasamy
Keyword(s):  
Analytical Method ◽  
Mobile Phase ◽  
Method Development ◽  
Degradation Products ◽  
High Specificity ◽  
Cost Effective ◽  
Review Literature ◽  
Phase Selection ◽  
Drug Products ◽  
Selection Of

Pharmaceutical analysis is one of the most challenging fields of analytical chemistry. Pharmaceutical analysts carry out the qualitative and quantitative control of APIs and drug products and also develop and validate appropriate methods. One of my main goals was to develop modern, rapid, precise and reproducible, but also cost-effective HPLC assay methods which are generally available and applicable for most users. The aim of this work was to develop LC methods for both compounds. The assay of erythromycin by LC offers several advantages, such as high specificity, the possibility of determining and quantifying impurities and degradation products, and improved accuracy. The developed methods were validated. My whole work containing following plan of work as Selection of drug, Review Literature, FITR of both drugs and Mixture, Preparation of standard solutions, Preparation of sample of pure drug in Standard solution, Method development by HPLC (as Selection of solvents to be used as diluents and mobile phase, Selection of wavelength, Selection of mobile phase and Selection of chromatographic conditions) Preparation of Mobile phase, Preparation of standard calibration curve combination of drug, Optimization of HPLC condition using box behnken design. Validation of analytical method following parameters as per ICH guidelines. (i). System suitability (ii). Linearity and range (iii). Specificity (iv).Accuracy and precision (v). Limits of detection (LOD) and Quantitation (LOQ). (vi). Selectivity and (vii).Robustness.

Agency Theory, Drug Formularies, and Drug Product Selection: Implications for Public Policy

1998 ◽  
Vol 17 (2) ◽  
pp. 287-295 ◽  
Author(s):  
David A. Mott ◽  
Jon C. Schommer ◽  
William R. Doucette ◽  
David H. Kreling
Keyword(s):  
Public Policy ◽  
Agency Theory ◽  
Drug Product ◽  
Goal Conflict ◽  
Drug Selection ◽  
Drug Products ◽  
Agency Relationships ◽  
Selection Decisions ◽  
Future Policy ◽  
Selection Of

The authors describe the pharmaceutical utilization system and present the conceptual framework for agency theory. They then apply agency theory to the selection of pharmaceuticals and the role of drug formularies in drug selection. The use of drug formularies can increase the goal conflict and uncertainty related to the selection of drug products. The authors address public policy and research directions to suggest ways of reducing the level of goal conflict and uncertainty associated with drug selection. Recognition of agency relationships and the environment surrounding agency relationships appear to be important for the development and analysis of future policy regarding selection decisions pertaining to pharmaceuticals.

Cognitive gadgets and cognitive priors

2019 ◽  
Vol 42 ◽  
Author(s):  
Gian Domenico Iannetti ◽  
Giorgio Vallortigara
Keyword(s):  
Cognitive Neuroscience ◽  
Selection Of

Abstract Some of the foundations of Heyes’ radical reasoning seem to be based on a fractional selection of available evidence. Using an ethological perspective, we argue against Heyes’ rapid dismissal of innate cognitive instincts. Heyes’ use of fMRI studies of literacy to claim that culture assembles pieces of mental technology seems an example of incorrect reverse inferences and overlap theories pervasive in cognitive neuroscience.

Note on Selection of Coordinate Systems for Geodynamics

1975 ◽  
Vol 26 ◽  
pp. 395-407
Author(s):  
S. Henriksen
Keyword(s):  
Sea Level ◽  
The Other ◽  
Coordinate Systems ◽  
Mean Sea Level ◽  
The Earth ◽  
The One ◽  
Static Systems ◽  
Selection Of

The first question to be answered, in seeking coordinate systems for geodynamics, is: what is geodynamics? The answer is, of course, that geodynamics is that part of geophysics which is concerned with movements of the Earth, as opposed to geostatics which is the physics of the stationary Earth. But as far as we know, there is no stationary Earth – epur sic monere. So geodynamics is actually coextensive with geophysics, and coordinate systems suitable for the one should be suitable for the other. At the present time, there are not many coordinate systems, if any, that can be identified with a static Earth. Certainly the only coordinate of aeronomic (atmospheric) interest is the height, and this is usually either as geodynamic height or as pressure. In oceanology, the most important coordinate is depth, and this, like heights in the atmosphere, is expressed as metric depth from mean sea level, as geodynamic depth, or as pressure. Only for the earth do we find “static” systems in use, ana even here there is real question as to whether the systems are dynamic or static. So it would seem that our answer to the question, of what kind, of coordinate systems are we seeking, must be that we are looking for the same systems as are used in geophysics, and these systems are dynamic in nature already – that is, their definition involvestime.

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