Oral Dosage Forms Research Articles

Stability-indicating RP-HPLC method development and validation for the quantification of amlodipine besylate and valsartan tablets in solid oral dosage form.

The present study discusses the development of simple, rapid, specific, precision, accuracy, stability indicating the HPLC method for the analysis of amlodipine besylate and valsartan tablet dosage form. The chromatographic separation was achieved using phosphate buffer with 1% triethyl amine (pH3.0) as mobile phase-A and mixed Methanol and buffer in the ratio of (65:35)(v/v) as mobile phase-B. The detection of components was made at 237 nm for amlodipine besylate and valsartan. Analytical techniques should enrich sensitivity and specificity for the estimation of pharmaceutical drug products. Evaluated stress studies under different types of ICH conditions. The optimized HPLC method was validated as per the current ICH guidelines. The validated HPLC method was obtained highly specific with linearity ranging between 25 and 200 μgmL-1 of amlodipine besylate and 40-320 μgmL-1 of valsartan and both components correlation coefficient was > 0.999. The method showed high accuracy more than 97%. In stress studies, amlodipine besylate and valsartan were found to be sensitive to acid stress conditions and oxidation stress conditions. The method was found to be suitable for the quality control of amlodipine besylate and valsartan in the tablet as well as in stability-indicating studies. The method was applied to the analysis of stability samples.

Formulation and Optimization of Fast Dissolving Tablets of Zidovudine.

Fast-dissolving tablets (FDTs) have emerged as a prominent alternative to conventional oral dosage forms, particularly for drugs requiring rapid onset of action. This study aims to formulate and optimize fast-dissolving tablets of zidovudine, an antiretroviral medication used in the treatment of HIV/AIDS. The primary objective was to enhance patient compliance by ensuring the tablet disintegrates and dissolves quickly in the oral cavity without the need for water. Using various superdisintegrants like sodium starch glycolate and cross-carmellose sodium into, multiple formulations were prepared. The optimized formulation was evaluated based on pre-compression and post-compression parameters, including hardness, friability, disintegration time, dissolution profile, and drug content uniformity. The study found that the incorporation of superdisintegrants significantly improved the dissolution rate of zidovudine, thus offering a promising approach for patients with swallowing difficulties and ensuring better therapeutic efficacy.

Study on the Related Substance of Lamivudine by A Validated HPTLC Method in Oral Dosage Forms

Lamivudine is an anti-retroviral drug available in the formulation of tablets and oral solution. The selected compound Salicylic acid is categorized as Lamivudine impurity C. An HPTLC method was developed and validated for the estimation of Lamivudine in bulk and oral dosage forms. The chromatograms were developed using a mobile phase of methanol: water: ethyl acetate in the ratio 4:2:4, v/v/v on pre-coated plate of silica gel 60 F254 and quantified by densitometric absorbance mode at 233nm. The Rf values were 0.76±0.03 and 0.65±0.02 for Lamivudine and Salicylic acid respectively. The linearity was found to be within the range of 500-3000 ng/band for Lamivudine and 50-300ng/band for Salicylic acid. The lower limits of detection and quantification were 21.24ng/band and 64.37ng/band for Lamivudine and 8.47ng/band and 25.68ng/band for Salicylic acid. The statistical evaluation by the %RSD calculation for accuracy and precision were below 2. The validated method was applied to detect and quantify Salicylic acid in the tablets of two dosage forms and the oral solution prepared as admixture. The quantified amount of the impurity C was found to be within the limits in the tablets and not detectable in the oral solution. This method can be adopted to determine Lamivudine and its impurity C in the API and different dosage forms.

3D printed personalized therapies for pediatric patients affected by adrenal insufficiency

ABSTRACT Background Adrenal insufficiency is usually diagnosed in children who will need lifelong hydrocortisone therapy. However, medicines for pediatrics, in terms of dosage and acceptability, are currently unavailable. Research design and methods Semi-solid extrusion (SSE) 3D printing (3DP) was utilized for manufacturing of personalized and chewable hydrocortisone formulations (printlets) for an upcoming clinical study in children at Vall d’Hebron University Hospital in Barcelona, Spain. The 3DP process was validated using a specific software for dynamic dose modulation. Results The printlets contained doses ranging from 1 to 6 mg hydrocortisone in three different flavor and color combinations to aid adherence among the pediatric patients. The pharma-ink (mixture of drugs and excipients) was assessed for its rheological behavior to ensure reproducibility of printlets through repeated printing cycles. The printlets showed immediate hydrocortisone release and were stable for 1 month of storage, adequate for prescribing instructions during the clinical trial. Conclusions The results confirm the suitability and safety of the developed printlets for use in the clinical trial. The required technical information from The Spanish Medicines Agency for this clinical trial application was compiled to serve as guidelines for healthcare professionals seeking to apply for and conduct clinical trials on 3DP oral dosage forms.

Determination of bioequivalence between generic and reference drugs using laser-induced breakdown spectroscopy

BackgroundIn vitro bioequivalence studies are strictly limited to the comparison of dissolution performance to a reference drug. These studies are performed without considering the chemical similarity between the generic and reference drug formulations. This work has focused on developing a groundbreaking method based on the laser-induced breakdown spectroscopy (LIBS) technique for the in vitro bioequivalence determination of immediate-release solid oral dosage form generic drugs and as an alternative method for establishing the biowaiver of in vivo generic drug studies. ResultsThe novel LIBS-based methodology to determine in vitro bioequivalence is fast, easy to perform, and can be carried out without the requirement of tedious and complicated sample pre-treatment, nor expensive instrumentals and reagents, almost directly on the drug samples. Furthermore, the proposed methodology demonstrated that it is enough to identify the spectrochemical similarity of the formulation between generic drugs to a reference drug through the chemometric study of their LIBS spectra, based on the determination of the differentiation and similarity factors, f1 and f2, respectively, used in the pharmaceutical industry in this purpose. After analysing their LIBS spectra, the generic drugs selected for this work have all been shown to be in vitro bioequivalent, given their f1 values of less than 15 and f2 values greater than 50, according to the technical regulations on which the American and European medicines agencies are based for the approval of registration for generic immediate-release solid oral dosage form drugs. This has been evidenced even for drugs from Class III and Class IV of the biopharmaceutical classification system, whose active principle nominal concentration is very low as 0.1 and 0.25 mg/tablet, respectively. Significancefor the first time the LIBS technique has been successfully used in an advanced application for the pharmaceutical industry. The proposed method constitutes a reliable and specialized methodology for the establishment of formulation similarity between two drugs, without the requirement of separate identification of each of their components, which is a new and potential tool to determine the in vitro bioequivalence for generic immediate-release solid oral dosage form drugs.

PVA-based formulations as a design-technology platform for orally disintegrating film matrices

In the majority of pharmaceutical applications, polymers are employed extensively in a diverse range of pharmaceutical products, serving as indispensable components of contemporary solid oral dosage forms. A comprehensive understanding of the properties of polymers and selection the appropriate methods of characterization is essential for the design and development of novel drug delivery systems and manufacturing processes. Orally disintegrating film (ODF) formulations are considered to be a potential substitute to traditional oral dosage forms and an alternative method of drug administration for children and uncooperative adult patients, including those with swallowing difficulties. A multitude of pharmaceutical formulations with varying mechanical and biopharmaceutical properties have emerged from the modification of the original polymeric bulk. Here we propose different formulation approaches, i.e. solvent casting (SC), 3D printing (3DP), electrospinning (ES), and lyophilization (LP) that enabled us to adjust the disintegration time and the release profile of poorly water soluble haloperidol (HAL, BCS class II) from PVA (polyvinyl alcohol) based polymer films while maintaining similar hydrogel composition. In this study, the solubility of haloperidol in aqueous solution was improved by the addition of lactic acid. The prepared films were evaluated for their morphology (SEM, micro-CT), physicochemical and biopharmaceutical properties. TMDSC, TGA and PXRD were employed for extensive thermal and structural analysis of fabricated materials and their stability. These results allowed us to establish correlations between preparation technology, structural characteristics and properties of PVA films and to adapt the suitable manufacturing technique of the ODFs to achieve appropriate HAL dissolution behaviour.

The handling of hazardous medications by nurses and midwives: A retrospective cohort study

BackgroundOccupational exposure of healthcare workers to hazardous medications can be potentially harmful. Hazardous medications can be carcinogenic, developmentally toxic, reproductively toxic, genotoxic and/or toxic to organs at low doses. These hazardous medications can be used in many healthcare settings, but published research of occupational exposure has focused almost exclusively on cancer services. AimTo identify the healthcare settings where nurses and midwives are responsible for the administration of hazardous medications. MethodA retrospective cohort study was undertaken of all medication administration events occurring during a two-week period at a public metropolitan health service in 2023. All medication administration events from six hospital sites were identified using the electronic (Oracle Health-Cerner-Millennium®) and paper (Chemotherapy Chart) medication administration records. From all of the medications administered, the subset of medications classified as hazardous were identified based on the Victorian Therapeutics Advisory Group Framework for Handling of Hazardous Medicines (2021) and other guidelines. Poisson regression modelling was used to explore associations between the number of hazardous medications and the healthcare area where they were administered (p < 0.001). ResultsOf the 121,567 administration events, 6054 (5.0 %) involved hazardous medications. The healthcare areas with the highest rate of hazardous medication administration events, as a proportion of all medication administration events, were outpatient cancer service (301/695, 43.3 %), birth suite (13/86, 15.1 %) and mental health (404/4011, 10.1 %) areas. During the two-week period, 6054 hazardous medication administration events occurred, involving 117 different medications. The greatest number of these events took place in the medical (1729/6054, 28.6 %) and geriatric (1579/6054, 26.1 %) inpatient healthcare areas. A total of 1258 nurses and midwives were directly involved in either administering, or checking and witnessing the administration of hazardous medications to 996 patients (25.2 % of the total 3958 patients). Most hazardous medications administered to patients were in an oral dosage form (5426/6054, 89.6 %). ConclusionHazardous medications were administered in all healthcare areas, with the exception of endoscopy services. Nurses and midwives were at risk of occupational exposure from hazardous medications.

Advanced Oral Drug Delivery Systems for Combating and Preventing Paediatric Periodontal Disease

: The oral route is the most common route of administration of drugs. Over 90% of all the available marketed pharmaceutical products are oral formulations. Oral drugs are used in different courses of treatment including the prevention of tooth decay. Tooth decay is the permanent damage of the enamel which leads to the formation of cavities. It can be prevented with good oral hygiene and enough fluorides in the body. Fluorides can be administered both topically (toothpastes) and systemically (supplements). Fluoride supplements fall under oral drug delivery systems. They come in the form of tablets, lozenges, and liquids. However, challenges are faced when it comes to oral drug delivery in children. The development of paediatric drugs is a difficult undertaking since many pharmaceutically active compounds have low water solubility, instability, or an unpleasant taste. Children are unable to tolerate bitter or unpleasant- tasting formulations, as well as huge pills and capsules. Due to various biological, biochemical, and physical barriers faced by oral drug delivery systems, new approaches have been developed to address these challenges such as the application of nanotechnology in drug development. Jellies for oral administration on the other hand are a new approach for the delivery of drugs with bitter tastes as well as for age groups such as children and elders. They are clear, translucent, or non-greasy semisolid products that can be used both externally and internally. In-depth, aspects of these factors will be discussed in this review paper including oral dosage forms for paediatrics, tooth decay and its pathogenesis, preventive measures and setbacks of each measure as well as the future perspectives.

Development and characterization of transdermal drug delivery system of ramosetron HCL using different polymers and their effect on In-vitro release

Transdermal Drug Delivery Systems (TDDS) offer a controlled and consistent release of medications, bypassing first-pass metabolism and minimizing side effects associated with traditional oral and intravenous therapies. This study focuses on the development and evaluation of Ramosetron HCl transdermal patches designed for sustained release to manage nausea and vomiting. Ramosetron HCl, a selective 5-HT₃ serotonin receptor antagonist, was incorporated into various formulations using different grades of Hydroxypropyl Methylcellulose (HPMC), Polyvinyl Pyrrolidone (PVP K30), and Polysorbate 80. The patches were prepared by solvent casting and evaluated for various parameters including thickness, weight variation, drug content, folding endurance, tensile strength, and in-vitro drug release. The calibration curve for Ramosetron HCl in 7.4 pH phosphate buffer was established with a λmax of 240 nm. Fourier Transform Infrared Spectroscopy (FTIR) was employed to ensure compatibility between the drug and excipients. Formulation F5 demonstrated optimal properties, including satisfactory drug release profiles and mechanical strength. Stability studies of F5 showed that the formulation maintained its release characteristics under accelerated storage conditions (40°C / 75% RH) for up to three months. This study confirms the potential of Ramosetron HCl transdermal patches as an effective alternative to oral dosage forms, providing sustained drug delivery and enhanced patient compliance.

Personalization of lipid-based oral dosage forms via filament-based 3D-printing

While filament-based 3D-printing (3DP) is the most utilized 3DP technology in the pharmaceutical field, it has not been demonstrated for processing of drug-loaded lipid-based formulations. This work exploits hexa-glycerol ester of palmitic acid (Pg6-C16-P) as an advanced lipid material, loaded with felodipine as a poorly soluble model drug, for fabricating novel oral solid dosage forms (OSDFs) via filament-based 3D-printing. After material melt-blending, the formulation was extruded using the liquid feeding approach to obtain a mechanically manageable, and hence 3D-printable, drug-loaded lipid filament. The fabrication of geometries with variable infill densities was demonstrated. The extent of infill density was found to significantly impact the optimal printing parameters required to achieve the desired shape. The solid-state analysis confirmed the amorphous state of felodipine after 3DP. The release rate of the drug was studied via in vitro dissolution test and showed to be tunable based on the tablet geometry. It was also possible to tailor the design of the dosage form to perform similarly to a commercial product. The formulation was evidenced as safe via in vitro toxicity studies with improved felodipine solubility. This study establishes filament-based 3DP as an alternative platform viable for fabricating advanced lipid-based OSDFs, and concurrently, promotes Pg6-C16-P as a promising and high performing 3DP lipid material for drug delivery.

Off-the-shelf medication transformed: Custom-dosed metoprolol tartrate tablets via semisolid extrusion additive manufacturing and the perception of this technique in a hospital context

Pharmacies are currently unable to stock proper oral dosage forms for pediatric populations. This leads to manipulation of medications or the need to compound specialized medications, which can be a time-consuming process. Using Semisolid Extrusion (SSE) additive manufacturing (AM), specialized medications can be produced in an expedited process from off-the shelf medication in a hospital or outpatient pharmacy setting. In this study, tablets with a desired dose of 5 mg of metoprolol tartrate derived from commercial Seloken™ 50 mg tablets were 3D printed in a hospital setting. Validation testing was done on five batches, highlighting tablets with a high uniformity in mass and dimension, drug content, acceptable microbial assays, and prolonged release during in-vitro analysis. The average drug content found for the tablets was within ±6% of 5 mg for all batches produced. Comparisons were done between the SSE tablets and capsules produced in an external compounding facility, highlighting several positive aspects of SSE-produced tablets beyond simply shortening the production timeline. The SSE tablets printed in this study are characterized by their smaller size, enhanced prolonged release properties, and more uniform drug content across the tested samples. Additionally, interviews with pharmaceutical professionals were conducted to determine the positive aspects of SSE and further improvements to bring this technique as seamlessly as possible into the pharmacy. This study underscores the feasibility of employing SSE in the production of specialized medications within a hospital environment. Furthermore, it highlights the methodological advantages SSE offers over existing production standards, demonstrating its potential to improve pharmaceutical manufacturing in healthcare settings.

Biowaiver monograph for immediate-release solid oral dosage forms: Raltegravir potassium

The present monograph discusses the possibility of BCS-based biowaivers for immediate release pharmaceutical products containing raltegravir potassium, which is used to treat human immunodeficiency virus (HIV) infections. Raltegravir potassium can be assigned to BCS class II or IV since this compound has low solubility and uncertain permeability. Therefore, according to the ICH M9 guideline, it is not recommended to apply BCS-based biowaiver to approval of immediate release solid dosage forms of raltegravir potassium, either for new generic versions or when moderate to major changes in composition and/or the manufacturing method of the product are made.

Risperidone Pellets, Pycnogenol®, and Glucomannan Gummy Formulation for Managing Weight Gain and ADHD in Autistic Children.

Gummy formulations are defined as gradually or slowly released solid oral dosage forms. Risperidone is an atypical antipsychotic medication used to treat schizophrenia and autism-related irritability. This study presents the development of visually appealing, patient-tailored medicated gummies that act as a novel pharmaceutical form of Risperidone for pediatrics. In this study, two gummy bases were used, one containing Glucomannan and the other containing Gelatin as a gelling agent, where these gummy bases were loaded with coated Risperidone pellets with a controlled release layer. The final products were evaluated for their pH, viscosity, content uniformity, drug content, and dissolution profile. Both formulas showed proper rheology and met content and weight uniformity standards. The release rates for F1 and F2 in the acidic media were 25% and 11%, respectively, after 2 h. At the same time, a full-release profile for Risperidone was noticed in both formulae at pH 6.8 where the release lasts for 24 h. It can be concluded that the chewable semi-solid dosages (gummies) filled with coated pellets are suitable for pediatric patients since pediatrics have drug-related problems which can be solved using high gastro-resistance coated pellets, which also shows a proper release profile for the drug.

Development of Orodispersible Tablets with Solid Dispersions of Fenofibrate and Co-Processed Mesoporous Silica for Improved Dissolution.

Poor water solubility is an important challenge in the development of oral patient-friendly solid dosage forms. This study aimed to prepare orodispersible tablets with solid dispersions of a poorly water-soluble drug fenofibrate and a co-processed excipient consisting of mesoporous silica and isomalt. This co-processed excipient, developed in a previous study, exhibited improved flow and compression properties compared to pure silica while maintaining a high specific surface area for drug adsorption. Rotary evaporation was used to formulate solid dispersions with different amounts of fenofibrate, which were evaluated for solid state properties and drug release. The solid dispersion with 30% fenofibrate showed no signs of crystallinity and had a significantly improved dissolution rate, making it the optimal sample for formulation or orodispersible tablets. The aim was to produce tablets with minimal amounts of additional excipients while achieving a drug release profile similar to the uncompressed solid dispersion. The compressed formulations met the requirements for orodispersible tablets in terms of disintegration time, and the drug release from best formulation approximated the profile of uncompressed solid dispersion. Future research should focus on reducing the disintegration time and tablet size to enhance patient acceptability further.

Development, optimization, and characterization of vitamin C-fortified oleogel-based chewable gels and a novel nondestructive analysis method for the vitamin C assay

Chewable gels represent an excellent alternative to oral dosage forms, such as tablets and capsules, owing to their appealing appearance, easy swallowing, and attractive colors. Given the inherent instability of vitamin C, particularly within chewable gels, it is imperative to enhance its stability and mitigate its degradation during processing and storage. Oleogel, systems prepared through an environmentally friendly and pollution-free method, exhibit a three-dimensional network structure that eliminates oxygen, alleviates oxidation, and enhances vitamin C stability. This study focused on optimizing vitamin C-fortified oleogel-based chewable gels using Plackett–Burman and D-Optimal design methodologies to maximize vitamin C stability while maintaining favorable mechanical properties. The optimal formulation, Opt-C, was achieved by crystallizing the gel at -18 °C, incorporating 2.5 g of distilled monoglyceride (DMG), and maintaining an oleogel-to-chewable gel ratio of 10%. Opt-C was comprehensively characterized using differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR), and its stability was rigorously assessed. Furthermore, a nondestructive assay method for vitamin C determination in chewable gels was developed employing near-infrared spectroscopy (NIR) and chemometric techniques. Storage studies demonstrated that Opt-C retained 85% of its vitamin C content during accelerated tests over ten weeks, surpassing the 69% retention observed in the control chewable gel. Opt-C exhibited a slower release of vitamin C in simulated digestive fluids; however, this release profile did not adversely impact the overall availability of vitamin C. Ultimately, the developed multivariate model successfully predicts vitamin C concentration: root mean square error of calibration (RMSEC): 0.284, Rcal2\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\ ext{R}}_{\ ext{cal}}^{2}$$\\end{document}: 0.9906; RMSE cross-validation (RMSECV): 0.501, Rval2\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\ ext{R}}_{\ ext{val}}^{2}$$\\end{document}: 0.9722; RMSE prediction (RMSEP): 0.670, Rpred2\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\ ext{R}}_{\ ext{pred}}^{2}$$\\end{document}: 0.9154. This innovative approach enhances the stability of water-soluble vitamins in chewable gels.Graphical

Rational prescribing and dispensing of oral dosage forms of medicines to children: an observational study

IntroductionIrrational prescribing and dispensing of oral dosage forms of medicines to paediatric patients are major public health issues, especially in low-income and middle-income countries. Many challenges affect the rational use...

Modification of the Biorelevant Release Testing of Esophageal Applied Mucoadhesive Films and Development of Formulation Strategies to Increase the Mucosal Contact Time.

The increasing prevalence of esophageal disease highlights the clinical relevance of novel, long-lasting mucoadhesive oral dosage forms. The EsoCap device enables targeted local application of films in the esophagus. Biorelevant test systems such as EsoPeriDiss are essential for early formulation development. To this end, the developed and already described release model for simulating the esophagus is being further developed for its potential for biorelevant mapping of the application site through complete tempering and investigation of biorelevant release media. Particularly viscous saliva formulations led to an extension of the retention time. In addition, possible formulation strategies for increasing the retention time of esophageal applied films are being evaluated, such as different film thicknesses, polymer grades and the influence of different active ingredient properties on the retention time. For highly soluble active ingredients, the film thickness represents an option for extending the retention time, while for less soluble substances, the choice of polymer grade may be of particular interest.

Industry's perspective on challenges assessing the in vivo impact of removing titanium dioxide (TiO2) from drug products

The European Commission (EC) has tasked the European Medicines Agency (EMA) to provide a recommendation towards the acceptability of titanium dioxide (TiO2) in pharmaceutical products by early 2024 to inform on final decision in early 2025[1]. Unlike the already implemented ban of TiO2 in foods, removing this excipient from pharmaceutical products will likely have significant impact on the pharmaceutical industry, regulatory agencies, and patients. This commentary explores the challenges facing the pharmaceutical industry tasked with supporting the development and registration of TiO2 free (TF) drug products. Specifically, justification of formulation changes and potential impact to in vitro and in vivo performance, as well as differences in global regulatory comparative dissolution requirements to justify changing to TF drug product are discussed. Particularly, the uncertainties around how a formulation change such as removal of TiO2 from immediate release solid oral dosage forms will be viewed in Europe compared to other regions is discussed. To respond to these challenges and avoid disruption to the medicines supply chain in case in vitro data such as dissolution is either too challenging or insufficient to justify changing to TF product, pharmaceutical companies may have to decide if the level of risk is worth the effort needed to reformulate, develop, and register a new TF product.

Palatability evaluation of orally disintegrating tablets using a visual analog scale in clinical trials.

Visual analog scale (VAS) can be used to evaluate multiple parameters. There have been no reports on the verification of order effects or reproducibility of the VAS method for overall palatability of oral dosage forms. The purpose of this study was to assess the validity of a method for evaluating the palatability of orally disintegrating tablets (ODTs) using a 100-mm VAS. We conducted clinical trials to evaluate the overall palatability, taste, and scent of 3 ODTs (F1, F2, F3) that contained famotidine (20, 10, and 5mg, respectively). The study protocol was approved by the Research Ethics Committee of the University of Shizuoka, Japan (No. 21-36). To investigate the intergroup reproducibility of the VAS evaluation, 40 participants were divided into three groups, and each group underwent human gustatory sensation test of F1, F2, and F3, performed using a crossover design with 6 different tasting sequences. To evaluate intragroup reproducibility of the VAS evaluation, the participants assessed the same ODTs twice. The VAS scores for overall palatability followed the same order (F3>F2>F1) in all groups. The VAS scores for the overall palatability of F1, F2, and F3 did not significantly differ between the first and second evaluations. The Kruskal-Wallis test indicated a minimal impact of the assessment order on ODT evaluations. We confirm the reliability and reproducibility of the VAS method for evaluating ODT palatability. The VAS method for assessing ODT palatability provides accurate information and can contribute to the design and manufacture of patient-friendly pharmaceutical products.

Long-Term Stability of Glycopyrrolate Oral Solution Galenic Compound at Different Storage Conditions.

Glycopyrrolate is a competitive muscarinic receptor antagonist used in the treatment of sialorrhea, especially in pediatrics. Degradation research was conducted to better understand the stability of the active pharmaceutical ingredient (API). Using an HPLC-UV method, we evaluated the chemical stability of the oral solution of the galenic compound glycopyrrolate 0.5 mg/mL under different storage conditions. Method validation was performed according to the International Council for Harmonization (ICH) Q2(R2) guidelines. The results of the stability study of the galenic compound in different storage conditions, with the exception of those stored in glass containers at 45 °C for more than 3 months, were stable (100 ± 10% of the nominal concentration). The aim of this work was to study the stability of the galenic compound glycopyrrolate in two different types of containers and at three different storage temperatures. Glycopyrrolate showed degradation beyond the limits only in glass at 45 °C and after 2 months of storage. The results indicate that oral liquid dosage forms of glycopyrrolate are stable for at least 210 days when stored at room temperature or at 4 °C, in glass or PET, for at least 7 months, maintaining product quality according to the standards established by the European Pharmacopoeia, ensuring long-term coverage for pediatric patient therapies.