Determination Of Active Ingredients Research Articles

Identification of manufacturers and determination of active ingredients in medicinal products using a colorimetric method in the near-IR range with a smartphone

A non-destructive method for analyzing medicinal products (non-steroidal anti-inflammatory drugs, fluoroquinolones, acetylsalicylic acid, vinpocetine, tetracyclines) based on diffuse reflection of IR radiation using a smartphone and a device printed on a 3D printer is proposed. It was established that the diffuse reflection of IR radiation (850 nm) from tabletized medicinal products can be recorded using a smartphone camera. Blister packaging and tablet coating slightly reduce the intensity of the diffuse light reflection signal at a wavelength of 850 nm, as confirmed by a comparative analysis of colorimetric measurement results in medicinal product samples inside the packaging, outside the packaging, and on tablet fractures. A correlation between the analytical signal and the concentration of the active substance is observed regardless of the study variant. The data array was processed using principal component analysis (PCA), hierarchical cluster analysis (HCA), partial least squares regression (PLS), and least squares methods using PhotoMetrix PRO® software for smartphones. It is shown that these algorithms can identify drugs by their manufacturer and determine the concentration of active ingredients. The colorimetric signals from tablets of a single manufacturer form separate clusters on dendrograms created using the HCA algorithm. Data obtained using PCA indicate the location of signals from tablets of different manufacturers in separate quadrants, facilitating the identification of the pharmaceutical company. The use of chemometric analysis methods for determining the concentration of the active substance is considered.

Determination of Active Ingredients, Mineral Composition and Antioxidant Properties of Hydroalcoholic Macerates of Vinca minor L. Plant from the Dobrogea Area.

In recent decades, new alternative therapies using drugs containing active ingredients of natural origin have been a hot topic for medical research. Based on the confirmed therapeutic potential of the Vinca minor plant, considered in the specialized literature to be of pharmaceutical interest, the purpose of this study is to determine the chemical and mineral composition of the Vinca minor plant grown in the Dobrogea area, with a view to its use in the formulation of dermal preparations. For this purpose, plant materials were collected from the mentioned area and hydroalcoholic macerates of different concentrations were obtained: 40%, 70% and 96% from leaves (F40, F70, F96) and stems (T40, T70, T96) of Vinca minor plant to determine the optimal extraction solvent. The hydroalcoholic macerates were analyzed via the HPLC method for the identification and quantification of the main bioactive compounds, and two methods were used to evaluate their antioxidant properties: the DPPH radical scavenging test and the photochemiluminescence method. HPLC analysis showed the presence of four indole alkaloids: vincamine, 1,2-dehydroaspidospermidine, vincaminoreine and eburnamonine. Vincamine was the alkaloid found in the highest concentration in Vinca leaves (2.459 ± 0.035 mg/100 g d.w.). The antioxidant activity of Vinca minor hydroalcoholic macerates showed values between 737.626-1123.500 mg GAE/100 g d.w (DPPH test) and 77.439-187.817 mg TE/100 g d.w (photochemiluminescence method). The concentrations of toxic metals Cd, Cu, Ni, Pb in dried leaves and stems of Vinca minor, determined by AAS, were below detection limits.

Determination of active ingredients in formulated plant protection products by UHPLC-UV/MS

Determination of active ingredients in formulated plant protection products by UHPLC-UV/MS

Determination of active ingredients in antihypertensive drugs using a novel green HPLC method approach.

A novel, sensitive, fast, and pratic RP-HPLC methods were presented for the quantitative amounts of Telmisartan (TEL) and Olmesartan (OLM) in the presence of Amlodipin (AML) in a binary mixture of pharmaceutical preparation. Waters Spherisorb ODS-2 C18 column was used for separation. These methods were valid over linearity ranges of 2.5-30μμg/mlL, 2-85μμg/mlL, and 2-35μμg/mlL for OLM, TEL, and AML, respectively. The mobile phase system consisted of acetonitrile:methanol: phosphate buffer at pH 3.0 (65:5:30 v/v/v), and the flow rate was 1,5mlL/min for OLM and AML. The mobile system's other mixture (TEL and AML) was acetonitrile:methanol: phosphate buffer at pH 2.5 (65:5:30 v/v/v), and the flow rate was 1,5mlL/min. These procedures were successfully applied to bulk, laboratory synthetic mixture, and medicinal dosage forms to use active ingredients quantitatively. The studied methods were validated according to ICH guidelines. In the developed HPLC method, the limit of detection values was found to be 0.020μμg/mlL for TEL, 0.025μμg/mlL for OML, and 0.070μμg/mlL for AML. The correlation coefficients for the HPLC method were found to be 0.9938 for TEL, 0.9996 for OML, and 0.9982 for AML. The calibration range is between 2.5 and -30, 5-35, and 2-85μμg/mlL for OLM, AML, and TEL, respectively. The proposed HPLC method is a convenient, effective, sensitive, green, and time-saving method for the rapid determination of TEL and OLM in the presence of AML.

Determination of active ingredients in alcohol‐based gel by spectroscopic techniques and chemometric analysis

AbstractThe international public health emergency related to COVID‐19 caused by the SARS‐CoV‐2 virus has altered several production and registration criteria for sanitary products, including alcohol‐based hand sanitizers. In this work, we investigate the concentration of alcohol in sanitizers presented in gel form applying the principal component regression method on measurements using Infrared and Raman spectroscopic methods. The chemometric calibration is performed using isopropanol or ethanol as active agents, and the method is used to characterize several commercial samples. Furthermore, the results of the prediction of alcohol concentration, obtained by applying the principal component regression and partial least squares methods, in the spectroscopic techniques, were compared with each other and with the results provided by nuclear magnetic resonance. Our results show that spectroscopic techniques coupled with principal component regression are fast, low‐cost, and safe tools for the determination of alcohol concentration, regardless the gelling agent used.

Determination of active ingredients in commercial insecticides using spectral characteristics of Fourier transform infrared spectroscopy (FTIR)

Pesticides have become a basic necessity for yield development. This might be credited to the quickly expanding population, which has presented weight on the food creation industry.Fourier Transform Infra-red Spectroscopy utilizes sample with less course of action, less time consuming, simple, fast, non-destructive and environmental friendly infrared-based method. It makes use of Smart iTR window and pellets use on omnic transmission window. In FTIR the peaks formed for the representative sample are from 800 cm-1 to 4000 cm-1 of wavenumbers against the % transmittance. The FTIR spectra obtained for pesticide formulations were on par with the NIST (National Institute of Standards and Technology) spectra library. Comparing the commercial-grade spectra with the Spectrabase, NIST library and Bio-rad software showed the peak ranges for different functional groups of the compound and can be examined with KnowItAll software’s ProcessItIR and AnalyseItIR. We can obtain the active principle of the peak, peak intensities. This method can be viewed as genuine choices to long and tedious chromatographic strategies as a rule suggested for quality control of commercially accessible pesticide formulations and check for adultered formulations that harm agricultural produce.

Development of a Comprehensive HPLC Method for Determination of Product-related Impurities and Assay of Active Ingredients in Papaverine Hydrochloride Products

Abstract. Papaverine hydrochloride products are used as anticonvulsants in routine medical practice. Most of the approved product specification files include thin-layer chromatography for assessment of product-related impurities and UV spectrophotometry for determination of active pharmaceutical ingredients. An HPLC assay is not used for determination of papaverine hydrochloride in drug dosage forms.The aim of the study was to develop an HPLC test method for determination of product-related impurities and for quantification of papaverine hydrochloride in solutions for injection, tablets, and rectal suppositories.Materials and methods: samples of the following Russian-made papaverine products were used in the study: Papaverine, solution for injection, 20 mg/mL; Papaverine, rectal suppositories, 20 mg; Papaverine, tablets, 40 mg. The Agilent 1260 Infinity II DAD System was used for the HPLC assay, and the Agilent 8453Е UV-Vis System was used for recording UV spectra. The determination of product-related impurities and the assay of active ingredients were performed simultaneously by HPLC using a reversed-phase column Kromasil 100-5-C18, 250×4.6 mm, 5 μm, the gradient elution mode, and detection at 238 nm. Papaverine Hydrochloride USP RS, 99% purity, and Noscapine EP CRS were used as reference standards.Results: the study demonstrated that determination of product-related impurities and assay of active ingredients in papaverine products can be performed simultaneously using HPLC.Conclusions: the authors proposed an HPLC test method for determination of active ingredients in papaverine products, which is aligned with the “consistent standardisation” principle and can be recommended for inclusion into draft monographs for papaverine products.

Evaluation of Anti-depressant and Anti-anxiety Activity of Methanol Extract of Stachys annua L. in Mice

Background and objectives: Development of new medicines with fewer side effects and more efficacy is needed for treatment of depressive and anxiety disorders. The present study was designed to investigate the antidepressant and anti-anxiety effects of Stachys annua L. methanol extract in mice. Methods: The extract was prepared by maceration method and the total phenolic and flavonoid contents were determined by Folin-Ciocalteu and aluminum chloride methods, respectively. Elevated plus-maze (EPM) and open field tests (OFT) were applied to evaluate the anti-anxiety and locomotor activity of animals treated with the intraperitoneal (i.p.) extract (12.5, 25, 50, and100 mg/kg), respectively. Antidepressant activity was evaluated by forced swim test (FST) and tail suspension test (TST). Results:The total phenolic content of the extract was 54.13±0.01 mg of gallic acid equivalents per gram of dry extract and total flavonoid content was 67.89±0.005 mg of quercetin as equivalents/ g of extract. Intraperitoneal administration of the extract (50 and 100 mg/kg) significantly increased the percentage of time spent and the percentage of arm entries into the open arms of EPM and decreased locomotor activity, compared with the vehicle control group. In addition, the immobility time of animals significantly decreased in both FST and TST with doses of 25, 50, and 100 mg/kg of the extract, compared with the vehicle control group. Conclusion: The extract of Stachys annua L. might be used as an adjunct therapy in clinical studies for the treatment of depressive and anxiety disorders. However, determination of active ingredients needs further evaluation.

Simultaneous LC-MS Identification and Determination of Active Ingredients in Septolete, Calgel, and Novosept Forte Preparations

A method using ultrahigh-performance liquid chromatography in combination with high-resolution time-of-flight mass spectrometry was developed for simultaneous identification and determination of the active ingredients (cetylpyridinium chloride, benzydamine, benzocaine, lidocaine, and tetracaine) in Septolete, Calgel, and Novosept Forte preparations. Analytes were identified using retention times, exact masses of ions, and agreement of isotopic distribution patterns (mSigma). The detection limits and limits of quantitation were 0.001 – 0.005 and 0.005 – 0.01 ng/mL, respectively, for all studied analytes. The ranges of determined contents were 0.01 – 50 and 0.005 – 10 ng/mL. The method was verified using actual preparations. The relative standard deviations of the analytical results were <0.05.

Simultaneous Determination of Active Ingredients in Multicomponent Common Over the Counter Tablets in the Present of Parabens and 4-Aminophenol by HPLC

A new selective reverse-phase high-performance liquid chromatography method with an attitude of practical use in pharmaceutical laboratories for simultaneous determination of Ascorbic acid, Acetaminophen, phenylephrine, Caffeine, Pamabrom, Guaifenesin, Dextromethorphan, Pyrilamine, Chlorpheniramine maleate, Ibuprofen in the presence of Methyl, Ethyl, Butyl Parabens as preservatives has been developed and validated. These active pharmaceutical ingredients widely used in a variety of cough and cold medicines. The separation was carried out on an Atlantis dC18 column including 4.6 mm inner diameter, 150 mm length and particle size of 3 μm, using a mobile phase which consisted of an ion-pairing agent (sodium salt of heptane sulphonic acid) as a buffer solution mixed with acetonitrile as an organic modifier at a flow rate of 1 mL min−1 on a gradient system. The investigation was carried out on wavelength program detection to quantify the very low concentration of Dextromethorphan and Chlorpheniramine and high concentration of Acetaminophen, Guaifenesin, Ibuprofen, Ascorbic Acid at the wavelengths of 290 and 215 nm. The temperature was maintained at 40 °C. The method was shown to be linear (R2 > 0.996), accurate (recoveries 97.77–103.94%), precise (RSD ≤ 1.0%), sensitive, specific, simple, fast and robust. The proposed reverse phase-liquid chromatography method was successfully applied to the routine analysis of the Over-The-Counter tablets containing these active pharmaceutical ingredients without any interference with excipients and parabens and 4-aminophenol.

Determination of terazosin in the presence of prazosin: Different state-of-the-art machine learning algorithms with UV spectroscopy.

Counterfeit drugs have adverse effects on public health; chromatographic methods can be used but they are costly. In this study, we developed cost-effective and environmentally friendly methodology for the analysis of terazosin HCl (TZ) in the presence prazosin hydrochloride (PZ) using UV spectroscopy in conjunction with machine learning (ML) models. Variable selection algorithms were applied to select most informative spectral variables. Thirty-five ML models were assessed and their performances were compared. The models covered a wide range of prediction mechanisms, such as tree-based, linear, self-organizing maps, neural network, Gaussian process, boosting, bagging, Bayesian models, kernel methods, and quantile regression. The values of the root mean square error (RMSE), coefficient of determination (R2), and absolute mean error (MAE) were obtained for the evaluation of the developed models. According to the results of these performance indices, linear model showed the highest prediction capacity among all other models. RMSE, R2 and MAE values of (0.159, 0.997 and 0.131) and (0.196, 0.99 and 0.161) were obtained for train and test datasets, respectively. The predictive models in this study can be useful for the researchers who are interested to work on the determination of active ingredients in pharmaceutical dosage forms in the presence of interference using UV spectroscopy; therefore, it was used to determine TZ without interference of PZ.

Validation of Methods of Identification and Quantitative Determination of Active Ingredients in Films for Treatment of Caries of Dentin

Introduction. Even though a wide range of the products for caries treatment is available, the efficiency of its treatment with the traditional methods is 62,5–75,4%. As a result of the set of researches carried out at the Department of Pharmaceutical Technology of the Perm State Pharmaceutical Academy, in cooperation with the Department of Dentistry of the Advanced Training and Professional Retraining Faculty of E. A. Wagner Perm State Medical University, a medical method of moderate and advanced caries treatment with remineralizing gel and films is proposed. During the preparation of the product specification file for the dentin caries treatment film, validation of the methods of the active ingredients quality control has been undertaken.Aim. Validation of the methods of identity tests and of potency assays of dentin caries treatment films.Materials and methods. In order to achieve the aim, active pharmaceutical substances of pharmacopoeial quality have been used. As a base for developing the methods of identity tests the methods with distinctive reactions to cations and anions have been taken. For the potency assay of calcium chloride a complexometric back-titration has been used; photoelectric colorimetry for potassium phosphate dibasic and sodium fluoride; spectrophotometry for chlorhexidine bigluconate. Five production samples of the films were the object of the research.Results and discussion. Basing on the research results, the choice was made in favour of the methods of identity tests that are characterized by negative analytical response when applied to the model mixtures which are free from analyte and placebo, and by positive analytical response when applied to the model mixtures of various composition containing analyte. The validation characteristics of the methods of dentin caries treatment films potency assays, which may be included in the product specification file, have been studied.Conclusion. Validation results show that the chosen methods are specific for both identity tests and potency assays of active substances in the dentin caries treatment films; they are characterized by precision, repeatability and linear dependency in the analytical range of ±30% in regard to the specified active substance concentration in the films. All that allows using them for a reliable quality assessment.

Effect of egg white and honey enema on ulcerative colitis in an animal model

Egg and honey contain a variety of bioactive compounds that can influence pro- and anti-inflammatory pathways and have effects on oxidative stress. In this study, the effects of egg white and honey against acetic acid-induced colitis were investigated in rats. Forty adult rats were divided into five groups (n = 7), group I (normal saline), group II (egg white), group III (honey), group IV (Asacol® 100 mg/ml used as a positive control), and group V (combination of honey and egg white 50:50 v/v). Medications (2 cc/day) were administered rectally for a period of 6 days after induction of colitis using 2% acetic acid. Animals were killed on day 7 and colonic biopsies were taken for histopathological scoring. The concentration of malondialdehyde (MDA) and TNF-α was measured on the samples of the colon tissue that were frozen in liquid nitrogen. At 1 week, the histological damage was severe, and the MDA and TNF-α were high throughout the study without any treatment. Honey decreased the TNF-α and MDA tissue levels towards normal levels significantly (P < 0.05). Combination of honey and egg white was not better than honey alone as an anti-inflammatory agent. In the animal model of ulcerative colitis, rectal administration of honey significantly reduced the colonic inflammation. The present study indicates that honey is efficacious in the acetic acid-induced rat colitis model, but these results require further confirmation in human studies and determination of active ingredients.

Optimization of L-tryptophan and thiotriazoline compound analysis by high-performance liquid chromatography

Introduction. An actual task of modern medicine is the development of treatment methods of the central nervous system diseases. The solution of this problem was the creation of new, more effective neuropsychotropic drug that shows pronounced antidepressant, nootropic, neuroprotective and antioxidant effects based on the fixed combination of L-tryptophan with thiotriazoline. One of the steps in creating a new drug is the standardization of active ingredients.Today, much attention is being paid to new physical-chemical methods of drugs study, including high-performance liquid chromatography (HPLC). Increasingly, the HPLC method is used for the determination of active ingredients of organic nature, both in mono-preparations and in combined dosage forms.Therefore, we have proposed the HPLC method for new combined L-tryptophan and thiotriazoline drug in order to determine active substances based on their effects.The purpose of our study is to develop a method for the simultaneous standardization of L-tryptophan and thiotriazoline in an artificial compound by high-performance liquid chromatography, in particular the selection of the mobile and stationary phase.Materials and methods. In the first stage of our work, a selection of phase and eluents was carried out for L-tryptophan and thiotriazoline model compound in a ratio of 1:1. The analysis method of thiotriazoline in the reverse phase (C 18) using the eluents, which are water-methanol compounds, was taken as a basis.Results. In the course of study, it was found that the retention volume of both tryptophan and thiotriazoline decreased, and the peak distribution coefficient increased with the number of theoretical plates with increasing content of methanol in phosphate buffer compound. Therefore, as an eluent, attention was drawn to a solution of 20% methanol with 80 % phosphate buffer. Under these conditions, the tryptophan retention volume was 15.11 ml, thiotriazoline – about 6.05 ml, the efficacy of the chromatographic column, calculated on the tryptophan peak of about 3300 theoretical plates.Findings: A highly sensitive technic was developed as part of the study for the simultaneous determination of L-tryptophan and thiotriazoline in a model mixture by HPLC (high performance liquid chromatography method, that is planned to be used in further study, was developed as a part of the study. The method is developed not only for L-tryptophan and thiotriazoline standardization in the combined drug, but also for their determination in biological fluids.

Colorimetry and Indirect X-ray Fluorescence Determination of Active Ingredients in Tetracycline Hydrochloride Drug and Injection Solution of B12 Vitamin Using of Polyurethane Foam Sorbents

The simple and available technique of colorimetry and indirect X-ray fluorescence determination of tetracycline hydrochloride (in the form of colored complex with iron(III) ions) and cyanocobalamine (in the form of the colored thiocyanate complex with cobalt(II) ions) is offered. The analytes were separated from the accompanying components by sorption to polyurethane foam based on ethers. The conditions of sorption separation and measurement of analytical signal of these substances are optimized. The obtained results of tetracycline drugs and injection solution B12 vitamin are in satisfactory agreement with data declared by the manufacturer.

Determination of active ingredients in Chinese medicine Danning Tablets using dispersion solid-phase extraction by molecular imprinting nanomaterials coupled with HPLC-DAD

A reliable pretreatment method of magnetic molecularly imprinted polymers/dispersive solid-phase extraction was developed for selectivity and enrichment of targets.

Determination of active ingredients in matrine aqueous solutions by mid-infrared spectroscopy and competitive adaptive reweighted sampling

In this paper, we use MIR and variable selection techniques to determine the active ingredients of matrine aqueous solutions. Competitive adaptive reweighted sampling (CARS) was engaged to investigate effective variables and compared with full-spectrum partial least squares (PLS) regression. Results indicate that MIR is very efficient in aqueous solutions quantitative determination. In the meantime, CARS is proved to be an effective variable selection approach to eliminate spectral redundancy.

Hollow Fiber/Solvent Bar Microextraction Coupled with High Performance Liquid Chromatography for Preconcentration and Determination of Tanshinones and Salvianolic Acids in Radix Salvia miltiorrhiza

Hollow fiber solvent bar microextraction coupled with high-performance liquid chromatography was developed for the preconcentration and determination of active ingredients in Radix Salvia miltiorrhiza. These ingredients include dihydrotanshinone I, cryptotanshinone, tanshinone I, tanshinone IIA, salvianolic acid B, danshensu, and protocatechuic aldehyde. To evaluate the technique, seven compounds of varying polarity were used as model analytes, and a polyvinylidene fluoride hollow fiber (1.0 cm) with octanol (2 µL) was used as microextraction bar. The extraction conditions, including the identity of the hollow fiber, organic solvent, pH, salt addition, agitation speed, extraction time, and volume, were investigated and optimized. The extraction mechanism was analyzed and verified. The two main parameters, extraction recovery and enrichment factor, were obtained. Under the most favorable conditions, the enrichment factors of the analytes were 0.7–612, the limits of detection were below 1.11 ng mL−1, and the recoveries were between 95.4% and 101.3%. Thus, hollow fiber solvent bar microextraction is simple, rapid, and practical with a wide range of potential applications.

RP-HPLC in determination of seven active ingredients in blood-invigorating and stasis-removing prescription

Objective To develop an RP- HPLC method for determination of tanshinol,protocatechualdehyde, paeoniflorin,puerarin,ferulic acid,tanshinoneⅡA and astragaloside in blood-invigorating and stasis-removing prescription(BSP).Methods The analysis was performed with a column of Waters Symmetry ShieldTM RP C18(150mm × 4.6mm,3.5 μm),and the mobile phase consisted of methanol-0.25% acetic acid.The flow rate was 0.8 mL/min and the column temperature was 30℃.UV was employed to determine the contents of tanshinol,protocatechualdehyde,paeoniflorin,puerarin, ferulic acid and tanshinoneⅡA,and the detection wavelength was set at 280nm.Evaporative light scattering detection(ELSD) was employed to determine the contents of astragaloside.The temperature of drift tube was 90℃ and the gas flow was 2.8L/min(compressed air).Results The linearity was obtained over 0.01-0.80μg(r=0.999 8)for tanshinol,0.005-0.4 μg(r=0.999 7)for protocatechualdehyde,0.05-4μg(r=0.999 8)for paeoniflorin,0.005-0.4μg(r=0.999 7)for puerarin,0.006-0.5μg(r=1)for ferulic acid,0.005-0.4μg(r=1)for tanshinoneⅡA,and 0.031-2.46μg(r=0.999 3)for astragaloside.The recoveries were all between 97.0%-101.0%,and RSDs were all less than 2%.The contents(mean) of tanshinol,protocatechualdehyde,paeoniflorin,puerarin,ferulic acid,tanshinoneⅡA and astragaloside in three batches of samples were 1.15,0.13,4.48,0.80,0.72,0.31and 3.12mg/g,respectively.Conclusion The method in our study is convenient,accurate and sensitive,and it provides a reference for the determination of active ingredients in BSP.

Treatment Fidelity in Early Childhood Special Education Research

Although this special issue on treatment fidelity is extremely timely for the field of early childhood special education (ECSE), this issue comes somewhat late in the history of conversations about the importance of information about treatment implementation. In 1980, Billingsley, White, and Munson discussed the need for treatment fidelity reliability in single case design studies. Blase, Fixsen, and Phillips (1984) pointed out the need to discriminate implementation outcomes from effectiveness outcomes in single-case and group design studies. In the two decades that followed, Fixsen, Blase, and others argued that only when effective practices and programs are fully implemented should we expect positive outcomes (Bernfeld, 2001; Fixsen & Blase, 1993; Institute of Medicine- Committee on Quality of Health Care in America, 2001; Washington State Institute for Public Policy, 2002; cited in Fixsen, Naoom, Blase, Friedman, & Wallace, 2005). Discussion of treatment fidelity has become more frequent in the last decade, fueled by changing standards for methodological rigor in educational research and public concern for implementing evidence-based practices in school and community settings (e.g., Borrelli, 2011; Elliott & Mihalic, 2004; Kratochwill & Stoiber, 2002; Stockard, 2010).The current issue provides representative sample of where the field of ECSE stands in the evolving consideration of implementation fidelity. These six articles link emergent conceptual frameworks in treatment implementation fidelity to the training and coaching process used for professional development (PD) in ECSE and to measuring fidelity of interventions in literacy, behavior disorders, social emotional support, and family interventions. Two articles report specifically on the progress toward reporting implementation fidelity in the field of ECSE.Dunst, Trivette, and Raab (p. 85) introduce an implementation science framework and provide specifications for measuring fidelity in ECSE research. In introducing this framework, they propose the use of the term implementation to refer to a specific set of [professional development] activities designed to put into practice an [intervention] activity. They argue that the use of any type of early childhood intervention practice requires attention to not only the fidelity of the intervention practice but also the fidelity of the methods used to promote the use of that practice. They also point out the need for understanding the active ingredients of implementation practices and interventions. Essentially, measurement of fidelity should index the active ingredients of implementation and intervention; further, the determination of active ingredients should be linked to research-based evidence of effectiveness. Dunst et al. provide conceptual model and analytical framework for linking variations in implementation fidelity, variations in the intervention as delivered, and practice outcomes for children and families. They illustrate the application of this model using data from Head Start research project in which teachers were taught to implement early literacy practices.Powell and Diamond's (p. 102) argument for the application of implementation science principles in examining PD in experimental studies of language and literacy instruction for preschoolers follows the logic offered by Dunst et al. Powell and Diamond propose that critical link in the PD pathway, the individualized coaching provided to teachers as means of training them to use new intervention procedure, is largely black box. They use their conceptual framework for coaching (Powell & Diamond, 2013) that emphasizes structure, content, and process to describe the impact of coaching on teachers' implementation of evidence-based literacy practices. The procedures for coaching were derived from series of iterative experimental PD studies. In this issue, they report data from hybrid coaching-based PD program offered to Head Start teachers. …