Pharmaceutical Tablet Formulations Research Articles

Development of Analytical Quality by Design RP-HPLC Method and Its Validation for Estimation of Gefitinib from Bulk, Tablet Dosage Form and Complex Nanoformulation.

Estimation of the drug and development of the method is a critical aspect of formulation development and a critical factor for analytical scientists. Gefitinib is a poorly soluble anticancer drug. The present research enlightens the topic of the development of innovative quality by design methods for the estimation of Gefitinib (GF) from bulk, pharmaceutical tablet formulation and complex nanoformulations. To simplify the estimation of poorly soluble drugs like GF, Response Surface Methodology (RSM) was adopted with effective leverages to obtain precise computation design space using the Box-Behnken Design (BBD) model. The major 3 mixed effect independent factors (Percentage of Buffer, pH of buffer and flow rate) were screened with 3 prominent dependent responses (viz., Theoretical Plate, Retention Time, and Tailing Factor) selected for optimal analysis. Furthermore, co-processed steps were employed for the estimation of the analyte from the complex formulation. The RP-HPLC method utilizes the quality by design (QbD) approach can effectively estimate the analyte concentration of less than 4.5 min. The developed method was economically robust, and sensitive and shows a % relative standard deviation (%RSD) of less than 2% for all the selected validation parameters. The estimated design space suggests the highest desirability (R2-0.998) at 60% of buffer in the mobile phase, pH 4.25, and flow rate of 0.7 mL/min. The QbD approach was used to design and develop the method by understanding the interaction between dependent and independent variables to get the optimum values. The developed method was validated successfully and can be useful for formulation scientists to estimate drug concentration and drug release profiles from complex nanoformulations. The analytical approach was designed and quantified using a quality-by-design approach to make the RP-HPLC method more robust and efficient for the estimation of analytes from complex nanoformulations. The method is also useful to eliminate the interfering molecule during estimation by employing co-processing steps. The developed method saves time, and cost of solvent and employs QbD as a requirement of recent regulatory concern.

Successful Formulation Window for the design of pharmaceutical tablets with required mechanical properties

Pharmaceutical tablet formulations combine the active ingredient with processing aids and functional components. This paper evaluates compressibility based predictive models for binary and ternary formulations to establish an acceptable range of tablet compression parameters that satisfy prescribed quality target criteria for tablets including minimum tablet strength and processing constraints such as maximum ejection stress and maximum compaction pressure. The concept of Successful Formulation Window (SFW) is introduced. A methodology is proposed to determine the SFW for a given formulation based on compaction simulator data collected for individual formulation components. The methodology is validated for binary and ternary mixtures and lubricated formulations. The SFW analysis was developed to support tablet formulation design to meet mechanical requirements.

Development and validation of a stability-indicating RP-HPLC method for estimation of Lefamulin in pure and pharmaceutical drug products

BackgroundCommonly occurring serious lung parenchymal infection is community-acquired bacterial pneumonia (CABP). Lefamulin acetate drug products are useful for the treatment of community-acquired bacterial pneumonia (CABP). The main objective of the study was the development and validation of a quick reverse-phase high performance liquid chromatographic analytical testing method for Lefamulin in pure and pharmaceutical dosage forms. The C18 column was the stationary phase for reverse-phase high performance liquid chromatographic separation, and the mobile phase consisted of 0.05 M phosphate buffer with a pH adjustment of 2.5 mixed with an equal volume of acetonitrile. A flow rate of 1.0 mL/min, a column temperature of 30 °C, an injection volume of 10 µL, and a detection wavelength of 210 nm were used as optimum conditions.ResultsThe developed method reported that Lefamulin peak’s retention time was 3.1 min, the average theoretical plate count 5000, and the average peak asymmetry 1.12. In both pure and pharmaceutical dosage forms, the method was found to be accurate, precise, specific, linear calibration curve, and robust. Quantitative assay results from laboratory-made formulations showed similarity to existing commercial products of Lefamulin. Lefamulin is stable in acidic and photolytic environmental circumstances, while it degraded in oxidative, basic, and thermal humidity environment, according to the results of stress studies.ConclusionsThe developed analytical method is fast, economic and stability indicating. It is useful for routine pharmaceutical analysis where the Lefamulin is synthesized in pure form, pharmaceutical tablet formulation, and parenteral dosage form, for their quality and safety.

Validated estimation of Gingerol and Curcumin in multicomponent herbal tablet by UV spectroscopy

Ginger, Zingiber officinale Roscoe Family- Zingiberaceae, has been used in Chinese and Indian folk medicine for centuries. Turmeric, Curcuma longa Linn is from the family of Zingiberaceae. There are no reported UV methods for simultaneous estimation of both the extracts, which is necessary in the development of Herbal formulation for these drugs. Hence, a simple UV spectroscopic method was developed and validated for direct estimation of gingerols and curcuminoids assay in pharmaceutical tablet formulations. Methanolic extracts of rhizome extracts were prepared and analyzed at λ max 280 and 421 nm respectively. The developed method was validated for intraday and interday variations as per ICH Q2A guideline and was found to be a stable method. Novel Pharmaceuticals, Nutraceuticals as well as cosmeceutical products can be conveniently analyzed using this method.

Development and validation of UV spectroscopic method for estimation of sacubitril and valsartan combination (LCZ696) in bulk and pharmaceutical tablet dosage forms

Sacubitril and valsartan combination is a member of a new class of agents called angiotensin receptor-neprilysin inhibitors (ARNI’s) which combine neprilysin inhibitor and angiotensin receptor blocker (ARB). It is currently indicated for treating patients with heart failure with reduced ejection fraction (HFrEF) in place of an angiotensin-converting enzyme (ACE) inhibitor or ARB alone. The aim of present investigation is to develop a simple UV spectrophotometric method for the determination of sacubitril and valsartan combination in its pure form and pharmaceutical tablet formulations in 0.1N HCl (pH 1.2) and pH 6.8 phosphate buffer, and further to validate the developed method. The combination in bulk was estimated at λmax of 253 nm in 0.1N HCl and pH 6.8 phosphate buffer. The observed λmax was close to the calculated λmax predicted using Woodward Fieser rules. The method was validated using analytical parameters like linearity, precision, and accuracy as per guidelines laid down by International Conference on Harmonization (ICH). Beer’s law was obeyed in the concentration range of 1–20 μg/mL in both media with correlation coefficient value of 0.999. The accuracy was found between 99-101% in both media. The method showed good reproducibility with % RSD values less than 2. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.5353 μg/mL, 1.6222 μg/mL in 0.1N HCl and 0.395 μg/mL, 1.198 μg/mL in pH 6.8 phosphate buffer respectively indicating its sensitivity. Molar absorptivity of the drug was found to be 3.84x104, 3.68x104 L mole-1 cm-1 and Sandell’s sensitivity values were found to be 0.0249 and 0.025 μg cm-1/0.001 absorbance unit in 0.1 N HCl and pH 6.8 phosphate buffer respectively. The assay values of the drugs in pharmaceutical dosage forms were also found close to the labelled claim. The results demonstrated that the procedure is accurate, precise, and reproducible besides being simple, economical, and less time consuming and hence, suitably applied for routine analysis of sacubitril and valsartan combination in bulk, marketed tablet dosage forms and in vitro dissolution samples.

Evaluation of Alternative Metallic Stearates as Lubricants in Pharmaceutical Tablet Formulation.

Magnesium stearate (MgSt) is perhaps one of the most frequently used lubricants in tablet formulation due to its superior lubrication capacity, yet it could also negatively affect the critical quality attributes of pharmaceutical products. Therefore, we provided a rather comprehensive evaluation of another two FDA-approved metallic stearates, sodium stearate (NaSt) and calcium stearate (CaSt), as alternative tablet lubricants. The primary objective of the present study is to comparatively evaluate the physicochemical properties and lubrication efficiency of the three metallic stearates. In addition, it was also aimed to specify the most influential factor for ranking and differentiating the lubricity of various lubricants using principal component analysis. Unit ejection force could be used herein as a simple and the most powerful parameter to evaluate the lubrication performance instead of the friction coefficient. The results suggested that CaSt, MgSt, and NaSt had similar impacts on the mechanical strength of tablets. However, CaSt exhibited insufficient lubrication effects as the formulations containing CaSt showed low pressure transmission ratios, high unit ejection forces, and high friction coefficients. In contrast, both MgSt and NaSt displayed satisfactory lubrication efficiency without negatively impacting tabletability. Notably, the lubrication performance of the formulation containing 0.5 wt% NaSt was almost identical to that of the formulation with 1 wt% MgSt, indicating that NaSt had a remarkable lubrication capability probably due to its high specific surface area. In summary, the findings of this investigation should provide practical information and feasible methodologies to readily determine the lubricity and to sensibly select alternative lubricants for pharmaceutical tablet formulations.

A Simplified Model Structure for Compression Characterization of Pharmaceutical Tablets

Despite -or maybe because- many shortcomings, Heckel's equation is by far the most investigated compressibility model for decades. The somewhat overlooked Gurnham equation is proposed as a more stable and better fitting compressibility model. Combining this equation with a linear model for the strength/pressure relation provides a composite function identical with the often-used Ryshkewitch equation for the relation between strength and porosity. It is thus questioned whether the three-dimensional compression characterization presented in USP monograph <1062> is correct. Substantial errors in computed parameters are revealed with consequences for reproducibility or inter-lab assessments. Elastic recovery is proposed as a more interesting and relevant characteristic in relation to pharmaceutical tablet formulation.

A NEW STABILITY INDICATING UPLC METHOD FOR THE DETERMINATION OF TWO ANTIDIABETIC DRUGS IN COMBINATION: APPLICATIONS TO BULK AND TABLET FORMULATION

Objective: This work was intended to develop a rapid and sensitive stability-indicating ultra-performance liquid chromatographic (UPLC) method for the determination of Metformin and Gliclazide simultaneously in their pharmaceutical bulk and tablet formulation. Methods: Separation was performed on Lunna C18 (100 mm x 2.6 mm, 1.6µ) column by using trifluoroacetic acid buffer: acetonitrile (70: 30, v/v) as a mobile phase at a flow rate of 1 ml/min and a wavelength of detection of 227 nm. Method validation and forced degradation studies were conducted per the respective guidelines of the International Conference on Harmonization. Results: Retention times under the optimized condition were 1.719 min and 2.845 min for Metformin and Gliclazide, respectively. Linearity ranged between 25.0-375.0 µg/ml for Metformin and 4.0-60.0 µg/ml for Gliclazide with a coefficient of determinations (r2) of greater than 0.99. The limit of detection values was 0.25 µg/ml for Metformin and 0.04 µg/ml for Gliclazide. Recovery results ranged from 99.63-101.23 %, and the % RSDs for the precision studies were less than 1.11% for both drugs. The % degradations at various stress conditions ranged from 14.0-5.0% for Metformin and 13.3-2.4% for Gliclazide. The analyte peaks were clearly resolved from the degradant peaks in forced degradation studies. Conclusion: A fast, sensitive and efficient ultra-performance liquid chromatographic method was successfully developed and validated for the concurrent estimation of Metformin and Gliclazide in their combination, and thus the proposed method can be effectively applied for routine quality control works.

A NOVEL VALIDATED STABILITY INDICATING ANALYTICAL HPTLC METHOD FOR QUANTITATION OF HYDROCHLOROTHIAZIDE AND LISINOPRIL IN TABLET FORMULATION

A new, simple and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of hydrochlorothiazide and lisinopril. Both the drugs were chromatographed on silica gel 60 F254 HPTLC plate using chloroform: methanol: ethyl acetate: acetic acid (7:2:1.0:0.2; V/V/V/V) as the mobile phase. Hydrochlorothiazide and lisinopril were quantified by densitometric analysis at 218 nm. The method was found to give compact bands for hydrochlorothiazide and lisinopril at Rf 0.43 and 0.75, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r2 0.9990 and 0.9992 in the concentration range 200–1200 ng band-1 and 250-1500 ng band-1, for hydrochlorothiazide and lisinopril, respectively. The method was validated as per the International Conference on Harmonization guidelines Q2(R1). The minimum detectable amounts were found to be 50.16 ng and 37.93 ng, whereas the limits of quantitation were found to be 150.48 and 113.92 ng for hydrochlorothiazide and lisinopril, respectively. Statistical analysis of the data showed that the method was precise, accurate, reproducible, selective and specific for the analysis of hydrochlorothiazide and lisinopril. The method was successfully employed for the routine quantitative estimation of hydrochlorothiazide and lisinopril in pharmaceutical tablet formulations.

EDTA salt modified carbon paste electrode for square wave voltammetric determination of theophylline in pharmaceutical tablet formulation.

In this study, a square wave voltammetric method for determination of theophylline in tablet formulation based on EDTA salt modified carbon paste electrode is presented. CV, FT-IR, and EIS results confirmed modification of the carbon paste with EDTA salt. In contrast to the unmodified carbon paste electrode, the modified carbon paste electrode showed irreversible oxidation of theophylline with considerable current enhancement. Investigation of the effect of scan rate on the Ip and Ep response of the modified electrode for theophylline revealed predominantly diffusion controlled oxidation kinetics. Under the optimized conditions, square wave oxidative peak current of theophylline in pH 7.0 PBS showed linear dependence on concentration in the range 10–200 μM with determination coefficient (R2), limit of detection, and limit of quantification of 0.99782, 0.0257 μM, and 0.0857 μM, respectively. Detection of an amount of theophylline in the analyzed tablet formulation with 1.85% error from its nominal content (120 mg/tablet) confirmed the accuracy of the developed method. Spike and interference recovery results of 98.59%, and 95.7–100%, respectively validated the applicability of the developed method for determination of theophylline content in tablet samples.

Ecofriendly Simple UV Spectrophotometric and Chemometric Methods for Simultaneous Estimation of Paracetamol Aceclofenac and Eperisone Hydrochloride in Pharmaceutical Formulation: Assessment of Greenness Profile

This work introduces three eco-friendly UV spectrophotometric methods for the simultaneous estimation of Paracetamol, Aceclofenac and Eperisone Hydrochloride in pharmaceutical tablet formulation. The procedures employed were simultaneous equation method and multivariate chemometric methods with phosphate buffer pH 7.80 as diluent. The simultaneous equation method encompasses absorbance measurement at three different wavelengths (λmax of the drugs). It exhibits linearity between 12–18 µg mL−1 for paracetamol, 3.69–5.53 µg mL−1 for Aceclofenac, and 2.76–4.15 µg mL−1 Eperisone hydrochloride. The results obtained for accuracy and precision by the simultaneous equation method were within the permissible limits. Principal component regression and partial least squares were the tools used for chemometric methods. The calibration set and prediction set were constructed, and the UV spectra were recorded in zero order mode, further subjected to chemometric analysis. The % recoveries obtained for Paracetamol, Aceclofenac, and Eperisone Hydrochloride by chemometric techniques showed good accuracy, and the results obtained for analytical figures of merit were acceptable. Statistical comparison of the assay results obtained for the proposed methods showed no significant difference found among the methods using one way analysis of variance. Greenness evaluation tools revealed the greenness profile of the proposed methods and found them to be ecofriendly. The described methods were appropriate for routine quality control laboratories, facilitating eco-friendly, fast, and cost effective determination of Paracetamol, Aceclofenac, and Eperisone Hydrochloride in Acemyoset P tablets.

STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DACLATASVIR IN PHARMACEUTICAL DOSAGE FORM

A simple, specific, precise, and accurate stability-indicating assay method using high performance thinlayer chromatography (HPTLC) is described for estimation of daclatasvir dihydrochloride (DCV) in bulk drug and in the tablet dosage form. The separations were achieved on prepared TLC plates precoated with silica gel 60 F254. The mobile phase developed and optimized for bringing out the separation involves toluene: methanol in the ratio of (6:4 V/V). The densitometric scanning wavelength selected was 312.0 nm. The compact bands of DCV were obtained at RF value of 0.702±0.032. The method developed was able to separate peaks of all the degradation products formed in ICH prescribed stress conditions with sufficient difference in their RF values. The developed method was validated for linearity and range, specificity, precision, accuracy, and robustness, and the results were found to be within acceptance criteria. The reliability of the method was evaluated when it was applied for the estimation of DCV in pharmaceutical tablet formulation and assay results gave good recovery.

Synthesis, characterization, and electropolymerization of a novel Cu(II) complex based on 1,10-phenanthroline for electrochemical determination of amoxicillin in pharmaceutical tablet formulations

UV–Vis and FT-IR results confirmed synthesis of a novel complex, aquachlorobis(1,10-phenanthroline)copper(II) iodidemonohydrate (ACP2CuIH), following a simple ion exchange reaction. CV and EIS results of potentiodynamically fabricated novel poly(ACP2CuIH)/GCE revealed modification of the electrode surface by a conductive, and electroactive polymer film leading to an increased effective electrode surface area. In contrast to the unmodified electrode, appearance of an irreversible oxidative peak at much reduced potential with five folds current enhancement at poly(ACP2CuIH)/GCE showed catalytic effect of the modifier towards oxidation of amoxicillin (AMX). DPV current response of poly(ACP2CuIH)/GCE showed linear dependence on concentration of AMX in the range 5 × 10−7 - 1.0 × 10−4 M with LOD and LOQ of 1.3 × 10−8, and 4.6 × 10−8 M, respectively. The AMX level in selected four tablet brands were in the range 95.2–101.8% of their nominal values. Spike recovery results of 98.8–100.6%, interference recovery results with less than 4.5%error, lower LOD and wider dynamic range than most of the previously reported methods validated the potential applicability of the present method based on the novel poly(ACP2CuIH)/GCE for determination of AMX in real samples with complex matrix.

The elastic recovery, ejection work, strength and dissolution of instant coffee tablet containing croscarmellose sodium disintegrant

Croscarmellose sodium disintegrant agent, commonly used in the pharmaceutical tablet formulation was employed in the instant coffee tablet formulation. Various compositions of croscarmellose sodium were added to the instant coffee tablet formulation; 20% w/w, 40% w/w, 60% w/w and 80% w/w respectively. These mixtures were then compacted through the uniaxial die compaction process forming 1 g tablets having 13 mm diameters each at various compaction pressures of 37.7 MPa, 75.4 MPa, 113.0 MPa and 150.7 MPa. The ejection work done when ejecting the tablet from the die was calculated to represent the frictional resistance to tablet motion during ejection. The tablet elastic recovery was measured as a quantitative measure of the tablet physical dimensional stability. Meanwhile, the mechanical strength, as well as the tablet dissolution, were also measured. The results showed that the croscarmellose composition and the compaction pressure affected all the studied tabletting properties. Generally, croscarmellose sodium increased the tablet elastic recovery and lowered the tablet ejection work, tensile strength and dissolution time in experimental conditions employed in this work. However, the extent of the croscarmellose sodium influence was clearly dependent upon the compaction pressures used for instant coffee tablet formation.

Development of validated analytical methods and stability indicating studies for pharmaceutical formulation

A simple, accurate rapid and precise has been developed and validated for estimation of Canagliflozin hemihydrate in Pharmaceutical Tablet Formulation by VU-Spectrophotometer and RP-HPLC Method. The successful estimation was carried out of the drug product is developed on the Jasco V-630 and Shimadzu-UV-1700 for VU-Spectrophotometer method and for HPLC successful estimation was carried out of the drug product is developed on the ACE Column C18 (150mm x 4.6mm, 5μm or equivalent) at ambient temperature using Acetonitrile: Orthophosphoric acid (1%) (60: 40 v/v) as mobile phase composition. The flow rate was adjusted to 1.0mL/minute and the absorption maxima were observed on UV detector at 290nm. Retention time for Canagliflozin hemihyd rate 3.0±0.5 min. The linearity was obtained in the concentration range of 80%-120% for Canagliflozin hemihydrate. For the HPLC method injection volume should be 20μL.The method was robust with respect to change in flow rate, temperature and composition of mobile phase. The method was validated statistically and applied successfully for the determination of Canagliflozin hemihydrate by VU-Spectrophotometer and RP-HPLC method. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for the routine determination of Canagliflozin hemihydratein pharmaceutical cream formulation.

Analysis on Bulk Pharmaceutical Formulation, Validation and Estimation Using Levetiracetam Methods

A new sensitive, specific, direct, exact and correct RP-HPLC technique is established and authenticated to estimate Levetiracetam in Majority and Pharmaceutical Tablet Formulations. An isocratic, turned around period HPLC system might have been created should differentiate the pill starting with the corruption products, Phenomenex Gemini 5µ C18 (2) 100A (250 x 4.60mm, 5 µ) section. Hamilton syringe (705 NR, 50 µL) might have been utilized to injecting example Furthermore standard result. The versatile stage comprises about mixture of Methanol: Acetonitrile in the proportion (90:10 v/v) toward A stream rate about 1.0 ml /min. UV identification might have been performed toward 210 nm. The linearity might have been made for Levetiracetam in the extent from claiming 5- 30µg/ml for relationship coefficient about 0.9997. LOD Also LOQ were found will make 0.076µg/ml Furthermore 0.23µg/ml individually. Maintenance duration of the time of Levetiracetam were found with make 2.281min and 2.274min. % recuperation might have been discovered on be 99.78-100.45 What's more %RSD might have been found for over ±2. Those system needs been approved as stated by ICH rules to linearity, precision, accuracy, robustness, ruggedness, LOD furthermore LOQ. Those produced approved system might have been effectively connected to dependable quantification about Levetiracetam to mass and pharmaceutical measurement type.

Simultaneous determination of atorvastatin calcium and ezetimibe in pharmaceutical formulations by liquid chromatography

A simple, precise and sensitive reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitation of atorvastatin calcium simultaneously with ezetimibe in pharmaceutical formulations. Chromatographic separation was achieved on a 250 × 4.6 mm, 5μ Hypersil® phenyl-2 column. Eluent was monitored by absorbance at 242 nm using a mixture of 0.1 M ammonium acetate (pH 6.5) and acetonitrile in the ratio of 28:72 (v/v). Calibration plots were linear in the concentration range of 12-52 μg mL-1 for both atorvastatin calcium and ezetimibe with correlation coefficient (R2) between 0.9966 and 0.9993. The total run time is less than 5 min. The proposed method was validated by testing its linearity, recovery, selectivity, repeatability and LOD/LOQ values and it was successfully employed for the determination of atorvastatin calcium and ezetimibe in pharmaceutical tablet formulations.

Fast and quantitative 2D and 3D orientation mapping using Raman microscopy

Non-destructive orientation mapping is an important characterization tool in materials science and geoscience for understanding and/or improving material properties based on their grain structure. Confocal Raman microscopy is a powerful non-destructive technique for chemical mapping of organic and inorganic materials. Here we demonstrate orientation mapping by means of Polarized Raman Microscopy (PRM). While the concept that PRM is sensitive to orientation changes is known, to our knowledge, an actual quantitative orientation mapping has never been presented before. Using a concept of ambiguity-free orientation determination analysis, we present fast and quantitative single-acquisition Raman-based orientation mapping by simultaneous registration of multiple Raman scattering spectra obtained at different polarizations. We demonstrate applications of this approach for two- and three-dimensional orientation mapping of a multigrain semiconductor, a pharmaceutical tablet formulation and a polycrystalline sapphire sample. This technique can potentially move traditional X-ray and electron diffraction type experiments into conventional optical laboratories.

Development and Validation of Stability Indicating UV-Visible Spectrophotometric Method for Simultaneous Estimation of Neem (Azadirachtin) and Curcumin in Pharmaceutical Tablet Dosage Form

The objective of the present study is to develop and validate a stability indicating UV-Visible spectrophotometric method for the simultaneous estimation of Azadirachtin and Curcumin complex in combined pharmaceutical tablet dosage form. The present method is based on simultaneous equation method based on measurement of absorbance at two wavelengths, 271nm and 421nm, λmax of Azadirachtin and Curcumin complex. The purposed method was validated statistically for linearity, accuracy, precision, repeatability, ruggedness, sensitivity as per international conference on harmonisation (ICH) guidelines. The drug substance was exposed to forced degradation studies. The method obeyed Beer Lambert’s law in the concentration range of 50-450 μg/ml for Azadirachtin and 200-1000 μg/ml for Curcumin complex. The high values of correlation coefficient (R2) indicated good linearity of calibration curve. % RSD associated with all the validation parameters were < 2 % confirming accuracy and precision. There were no significant changes in absorbance after performing the forced degradation studies. The % age of Azadirachtin and Curcumin complex was found to be 98.80 ± 0.92 and 95.80 ± 0.00 respectively. The proposed method can be successfully applied to the the routine in-vitro dissolution analysis of Azadirachtin and Curcumin complex in its combined pharmaceutical tablet formulations.

New modified release tablets of bisoprolol fumarate for the treatment of hypertension: characterization and in vitro evaluation

ObjectivesThe purpose of the study was to develop sustained release tablets containing bisoprolol fumarate and an innovative combination of Precirol ATO5 and hydroxypropyl methylcellulose, in order to conclude upon: properties of pharmaceutical tablet formulations, drug-excipients interactions, evaluate their in vitro release behavior. MethodsThe tablet formulations with rate controlling polymers were prepared by melt granulation technique. The physico-chemical characterization of new tablet formulation was performed by FT-IR spectroscopy, differential scanning calorimetry, thermogravimetric analysis and X-ray diffraction. The formulations were also evaluated for in vitro dissolution test to select the optimized formulation. ResultsStructural evaluation indicated the presence of interactions between tablet components which did not affect drug release. The tablets displayed good mechanical properties, with friability values close to zero and drug content was found to be uniform in all formulas. Release profile showed a tendency to follow Korsmeyer-Peppas and Higuchi kinetics. ConclusionsIn the present study we investigated the effect of concentration of matrix former compounds (hydroxypropyl methylcellulose and glyceril palmitostearate) on the release rate of bisoprolol fumarate. The study evidenced the assembling through physical bonds between the excipients and the drug, which do not affect the release of the bioactive compound.