Solid Dosage Forms Research Articles

The Quantitative Analysis of Solid Dosage Forms of Itopride using Raman Spectroscopy.

This study explores the application of Raman spectroscopy for identifying and quantifying itopride in solid dosage forms with varying concentrations of active ingredients and excipients. Raman spectroscopy provides a non-invasive, rapid, and accurate detection method that is ideal for pharmaceutical analysis. The Raman spectral features of itopride in solid dosage forms were analyzed using Principal Component Analysis (PCA) and Partial Least Squares Regression Analysis (PLS-RA) as multivariate data analysis techniques. PCA effectively distinguished Raman spectral data of various itopride drug samples. PLS-RA facilitated quantitative analysis, yielding an R2 value of 0.999%, indicating an excellent explanation of model variability. The root mean square error of calibration and prediction were 0.23 mg and 3.02 mg, respectively. Furthermore, PLS-RA accurately determined the active pharmaceutical ingredient concentration in unknown formulations, with a calculated concentration of 79.66/80 mg (w/w) compared to the actual concentration of 80/140 mg (w/w). These findings demonstrated that the concentration of itopride in pharmaceutical samples using an established Partial Least Squares Regression calibration model can be determined with reliability.

The revival of the mini-tablets: Recent advancements, classifications and expectations for the future.

The revival of the mini-tablets: Recent advancements, classifications and expectations for the future.

Supramolecular interaction of ketoprofen with native and hydroxypropyl beta-cyclodextrin: Improved solubility and anti-inflammatory.

Supramolecular interaction of ketoprofen with native and hydroxypropyl beta-cyclodextrin: Improved solubility and anti-inflammatory.

Investigation of the Relationship between the Chemical Stability of Itraconazole Adsorbed on Silica during Humidification and NMR Relaxation Using Time-Domain NMR.

Silica powder is an essential pharmaceutical ingredient, which in some combinations with drugs, causes chemical instability of the drug adsorbed on it. NMR measurements have been used to determine the drug adsorption state; however, the relationship between drug chemical stability and NMR relaxation, one of the NMR processes, is yet to be thoroughly studied. This work investigated the relationship between the chemical stability of itraconazole (ITZ)-adsorbed silica and its NMR relaxation. NMR can specifically observe 1H nuclei, and this feature was exploited to study only the T1 relaxation of these nuclei in the drug, excluding the silica signal composed of Si and O. ITZ, a poorly water-soluble model drug, was physically adsorbed on nonporous silica (Aerosil 200, AER), and mesoporous silica (Sylysia 320), and the 1H T1 relaxation was measured before storage using the time domain (TD)-NMR technique. The amount of ITZ degradant adsorbed in the silicas was also measured after storage at humidified conditions. Then, the relationship between the degradant amount of ITZ-adsorbed silica after storage and the T1 relaxation rate (1/T1) before storage was investigated. The ITZ-adsorbed silicas showed a positive correlation between the degradant amount and the 1/T1 value. ITZ-adsorbed AER showed a strong positive correlation (R2 = 0.751). Thus, the 1/T1 value may be an efficient parameter to determine the chemical stability of ITZ adsorbed on nonporous silica. The 1/T1 value measurement by TD-NMR could provide new insight for evaluating the chemical stability of solid dosage forms containing silica.

Application of the Quality-by-Design Approach at the Laboratory Stage of Tablet Development

INTRODUCTION. Quality by design (QbD) is a systematic approach to pharmaceu­tical development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management. The QbD approach facilitates the production of medicinal products with target characteristics and quality profiles. There are currently no specific guidelines for the application of QbD principles to the development of individual dosage forms.AIM. This study aimed to evaluate the possibility of and propose an algorithm for using QbD at the laboratory stage of pharmaceutical development for solid dosage forms, with tablets as a case study.MATERIALS AND METHODS. This study analysed publicly available regulatory documents, scientific publications, and guidelines on pharmaceutical development using general scientific methods, including comparative and logical analysis. The regula­tory documents analysed included those issued by the International Council for Harmonisation (ICH), the Eurasian Economic Commission, and the State Pharmacopoeia of the Russian Federation. The sources searched included electronic databases, such as PubMed, Web of Science, eLIBRARY.RU, and Google Scholar.RESULTS. Developing the quality target product profile (QTPP) and composition of tablets requires a comprehensive study of the active substance, as well as an assessment of its compatibility with the excipients. At the laboratory stage of pharmaceu­tical development, it is necessary to select and optimise the medicinal product composition while assessing potential risks. This approach provides for the preliminary identification of critical quality attributes, critical process parameters, and critical material parameters. This article presents an algorithm for applying QbD to tablet formulations at the laboratory stage of pharmaceutical development.CONCLUSIONS. When implemented at the laboratory stage, the proposed algorithm with QbD elements will improve the overall efficiency of pharmaceutical development.

Comparative Study of Herbal Chewable Tablet and Kofol Chewable Tablet

Developing a chewable, easily accessible pill for ginger (Zingiber officinale) that has antitussive qualities is the aim of this project. Solubility, hardness, friability, disintegration, and weight variation were assessed for each formulation. As a convenient and patient-friendly substitute for other dosage forms, chewable tablets have stood out, especially for patients who have trouble swallowing conventional solid oral dose forms.

Development of analytical method validation procedure for Fidaxomicin tablet for oral suspension

Analytical procedures for oral solid dosage forms are necessary to comply various validation criteria which mainly are the accuracy, precision, specificity, robustness, and limit of detection. For the Fidaxomicin tablets for oral suspension, we have checked all these parameters to ensure the efficacy of the formulation. In this research article, all above parameters are tested in line with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and United States Food and Drug Administration (USFDA) guidelines and results are reported in a scientific manner.

Raman spectroscopy for the quantitative and qualitative analyses of solid drug formulations of salbutamol.

Inhalable drugs are commonly used to treat different kinds of respiratory disorders, such as asthma, coughing, wheezing, and breathing difficulties. Salbutamol is an inhalable drug which is used to treat symptoms of acute obstructive lungs disease and asthma. In this research, Raman spectroscopy technique has been utilized to determine the quality and quantity of solid dosage forms of salbutamol drug. Eight formulations of solid drug Salbutamol, combination of excipients and API, were prepared and analyzed. The Raman spectral features showed significant change in their intensities as directly related to variation in the concentration of formulation. Raman spectral results were further assessed by principal component analysis (PCA) and partial least squares regression analysis (PLSR) which are very potent chemometric tools for the quantitative and qualitative analyses of the pharmaceutical drugs. PCA was found to be useful in discriminating the acquired Raman spectra of various salbutamol drug formulations in solid forms of dosage. Furthermore, PLSR model developed for analyzing the quantitative relationship between different formulated solid dosages of salbutamol drug. The prediction of model and the prediction of an unknown drug formulation's concentration is performed by PLSR model. A value of 0.9079 mg was found to be for the root mean square error of cross-validation (RMSECV) and good fit regression R2 was found to be 0.998. Moreover, API concentration (w/w) of unknownformulation of the drug was found to be 8.90mg (w/w) having actual concentration of 8mg (w/w).

Tuneable dissolution profile of tinidazole through thermoplastic polymer composites in low temperature 3D printing settings for pharmaceutical additive manufacturing applications.

In this study the first-time introduction of Kollidon® 25 (K25) thermoplastic polymer, which was not earlier explored in PBF-based 3D printing technology along with the simultaneous usage of Kollidon® SR (KSR) to form a thermoplastic polymer composite for the development of tunable solid oral dosage form (SODFs). In addition to this, a novel laser-absorbing dye i.e., Pigment Green 7 (PG-7) was also introduced to facilitate the laser sintering process of the used thermoplastic polymer composites. Sintered tablets obtained from the used thermoplastic polymer bed composites were systematically characterized using various analytical tools and in vitro examinations as well. The physicochemical characterization of all sintered tablet batches (B1-B7) was within the acceptable limit. Thermal and chemical analyses revealed no detrimental physical or chemical interactions between the components, as well as after exposure of sintered tablet batches to laser and temperature. Powder X-ray diffraction diffractograms suggested a change in the native state of tinidazole (TNZ, used as an active pharmaceutical ingredient) to amorphous due to the exposure of sintering parameters. Scanning electron microscopy micrographs of all batches showed intense fusion of the particles in the polymer composite. The sintered tablet batches B1 to B7 exhibited a drug content ranging from 90.36 ± 4.32% to 99.36 ± 1.24%. TNZ released in an acidic medium for up to 2.0 h from different sintered tablets were around 100% to 12% from B1 to B7 batches, respectively following alkaline medium for up to 12.0 h. TNZ release pattern was fine tuned in accordance with the changes in the composition ratio of Kollidon® 25 and Kollidon® SR polymers in order to get quick release to sustained release. This prepared unique thermoplastic pharmaceutical grade polymer composite might broaden the range of materials accessible for PBF-mediated 3D printing in pharmaceutical industrial applications in near future.

Various Aspects of Solid Dispersion Technology: A Review

Because of solubility issues, improving the bioavailability of drugs administered orally in solid medicament continue to be an obstacle for scientists dealing with the formulation design. A solid dosage form's absorption of somewhat insoluble medications may be slowed down by their rate of disintegration. Therefore, scientists have a problem in improving the solubility aspects of the poorly soluble drugs utilizing solid dispersion approach. Solid dispersion methods have generated a lot of attention because they can speed up the dissolution aspects of the highly lipophilic medications and comparatively increase the bioavailability by lowering particle size of drug, enhancing wettability and creating amorphous particles. A class of solid products with at least two separate ingredients, often a hydrophobic medication or a hydrophilic inert carrier, are referred to as solid dispersions. Standard formulations like tablets or capsules can be replaced with solid dispersion made utilizing a number of processes, and it offers numerous benefits over them. This review summarizes and aims to give an insight about BCS classification, types of solid dispersion, their mechanism for solubility enhancement, carriers employed, methods of solid dispersion preparation, advantages, limitations, characterization and research work related to solid dispersions.

Developing a behaviour change intervention using information about greenhouse gas emissions to reduce liquid antibiotic prescribing.

Developing a behaviour change intervention using information about greenhouse gas emissions to reduce liquid antibiotic prescribing.

Application of Density Functional Theory to Molecular Engineering of Pharmaceutical Formulations.

This review systematically examines the pivotal applications of the Density Functional Theory (DFT) in drug formulation design, emphasizing its capability to elucidate molecular interaction mechanisms through quantum mechanical calculations. By solving the Kohn-Sham equations with precision up to 0.1 kcal/mol, DFT enables accurate electronic structure reconstruction, providing theoretical guidance for optimizing drug-excipient composite systems. In solid dosage forms, DFT clarifies the electronic driving forces governing active pharmaceutical ingredient (API)-excipient co-crystallization, predicting reactive sites and guiding stability-oriented co-crystal design. For nanodelivery systems, DFT optimizes carrier surface charge distribution through van der Waals interactions and π-π stacking energy calculations, thereby enhancing targeting efficiency. Furthermore, DFT combined with solvation models (e.g., COSMO) quantitatively evaluates polar environmental effects on drug release kinetics, delivering critical thermodynamic parameters (e.g., ΔG) for controlled-release formulation development. Notably, DFT-driven co-crystal thermodynamic analysis and pH-responsive release mechanism modeling substantially reduce experimental validation cycles. While DFT faces challenges in dynamic simulations of complex solvent environments, its integration with molecular mechanics and multiscale frameworks has achieved computational breakthroughs. This work offers interdisciplinary methodology support for accelerating data-driven formulation design.

A Comprehensive Analysis of Market Forms and Analytical Methods for Metformin Formulations.

Metformin has been a cornerstone in the management of type 2 diabetes mellitus (T2DM) for more than 50 years, either alone or in combination with other therapies. This oral antihyperglycemic agent, also known as dimethylbiguanide, plays a crucial role in regulating noninsulin-dependent diabetes mellitus and is widely prescribed globally for various medical conditions. Recent advancements in its formulations have aimed to increase its effectiveness, tolerance, and nonglycemic effects. This review critically evaluates the analytical methods used to assess metformin formulations, including chromatographic and spectroscopic techniques, with a focus on sensitivity, specificity, and reliability. Comprehensive literature from various scientific databases was searched to gather information on metformin. Various formulations of metformin HCl, including hydrogels, solid dosage forms, mucoadhesive patches, lipospheres, and topical preparations, offer advantages like sustained release, improved bioavailability, and wound-healing potential. Analytical methods like RP-HPLC and UV-visible spectroscopy ensure the safety, stability, and accurate quantification of these formulations. These approaches support personalized treatment of T2DM, enhancing blood sugar control, therapeutic efficacy, and patient outcomes. This review offers valuable insights into metformin formulations and analytical aspects that researchers and pharmaceutical experts benefit in the further development and evaluation of metformin formulations.

Gastric stress events impact the bioavailability of a poorly soluble weak base dabigatran from pellet-filled capsules: An outcome from pharmacokinetic simulations based on biorelevant dissolution testing, machine learning, and a novel timewise first-order dissolution model.

Gastric stress events impact the bioavailability of a poorly soluble weak base dabigatran from pellet-filled capsules: An outcome from pharmacokinetic simulations based on biorelevant dissolution testing, machine learning, and a novel timewise first-order dissolution model.

Next-generation pharmaceuticals: the rise of sildenafil citrate ODF for the treatment of men with erectile dysfunction.

Orodispersible film (ODF) is one of the novel formulations that disintegrate rapidly in the mouth without the requisite for water compared to other conventional oral solid dosage formulations. This delivery system serves as a convenient mode of administration, especially in patients who have dysphagia and fluid restriction, being beneficial to pediatric, geriatric, and bedridden patients. A novel sildenafil ODF containing sildenafil citrate is formulated to be used in patients with erectile dysfunction (ED). This review discusses the advantages of ODF in improving compliance and satisfaction in these patients and describes the manufacturing techniques, evaluation tests, bioequivalence, and stability studies of sildenafil ODF. This formulation offers unique benefit to patients with ED by improving their acceptance and compliance and respecting their privacy and the need for a discreet treatment. Moreover, the comparison of pharmacokinetic parameters between the sildenafil ODF administered with and without water and the conventional film-coated tablet were similar. It also demonstrated reliable performance that yielded a consistent product, meeting all specifications at release and after three weeks of storage under stressed conditions (60°C). Sildenafil ODF warrants improved ease of intake, taste, portability, storage, and compliance among ED patients, making it the potential most preferred formulation and drug of choice.

Composites of Chitin as Excipient for Pharmaceutical Solid.

Chitin, the second most abundant biopolymer after cellulose, can function as an excipient for pharmaceutical solid dosage forms. Chitin, due to its chemical inertness, is useful in extending the shelf life of many drugs. Binary composites of chitin and another suitableexcipient can be formed to improve the compressibility and compatibility of chitin. Composites composed of chitin/CaCO2, chitin/CaHPO4, and chitin/MCC were prepared by slugging the powders using a single punch machine, ground, and screened over mish#22. Characterization of the composites was performed by measuring the density, particle size, and flowability of the powder composites. The compression behavior of the composites was performed utilizing Kawakita analysis. Characterization of the compacts (tablets) formed was undertaken by measuring the hardness (crushing strength), disintegration time, and friability of the tablets. Modeling and optimization of the performance of the various composites and the correlation between the input factors (compression force, chitin content, and additive type) and the responses (powder volume reduction and tablet hardness) were achieved by Response Surface Method (RSM) analysis. The tablet hardness was modeled by a linear model with both the compression force and the composite composition. The powder volume reduction was best modeled bya quadratic model with compression force and composite composition. One of the major conclusions from this work is the effect of synergy between different modes of deformation of binary excipients. In this regard, there is an impact of brittle excipients added to a plastically deforming excipient in improving the compressibility of a composite of chitin-CaHPO4 and chitin-CaCO3. The RSM models were in agreement with the compression analysis results using the Kawakita method.

Formulation and Evaluation of Fast Dissolving Oral Film of Promethazine Hydrochloride using Different Surfactant

Fast-dissolving oral delivery systems are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or chewing. This facilitates the rapid absorption in the oral cavity and reduces first-pass effects. The aim of this study is to formulate and evaluate the Fast dissolving Oral film of Promethazine hydrochloride as a strong antihistamine which are used to reduce nausea, motion sickness and improved bioavailability of drugs as compared to conventional solid oral dosage forms. The films were prepared Hydroxy propylmethyl cellulose E15 as a film base synthetic polymer and PEG400 (Poly Ethylene Glycol 400) as a plasticizer by solvent casting method. SLS (Sodium Lauryl Sulfate) and MCC (Micro Crystalline Cellulose) used as a surfactant in different concentration. Sucrose used as a sweetening agent and strawberry as a flavoring agent. Films were found to be satisfactory when evaluated for thickness, weight uniformity, in-vitro drug release, folding endurance, drug content and disintegration time. The surface pH of all the films was found to be neutral or minor change. Films in vitro drug release studies also done by using USP dissolution apparatus. The in vitro drug release in optimized formulation F2 was found to be 14.36% in 2 min. The optimized formulation F2 also showed satisfactory pH, drug content (97.41±0.54%), effective in vitro drug release (96.03±0.68% in 16 min), disintegration time of 09 seconds and satisfactory stability.The Promethazine hydrochloride fast dissolving oral film was formulated. The given film disintegrates within nine seconds which release drug rapidly and gives action.

A Cross-Sectional Study on Solid Oral Dosage Form Modifications among Older Patients Admitted to A Malaysian Teaching Hospital

INTRODUCTION: Older adults often require multiple medications, increasing their risk of polypharmacy and drug-related problems (DRPs). Solid oral dosage forms (SODFs) are the most common medication formulation used by patients. However, administering SODFs to older adults can be challenging, especially for those with swallowing difficulties, leading to practices such as crushing, splitting tablets, or opening capsules. These modifications can affect medication efficacy and safety. This study aims to examine the prevalence of SODF modification among hospitalized older adults, the methods used, the reasons for modification, and the appropriateness of these practices. MATERIALS AND METHOD: This cross-sectional study included patients aged 60 years and above admitted to the general medical ward of a tertiary teaching hospital. Eligible participants were identified through the hospital's electronic registration system. Sociodemographic and clinical data were collected using a standardized form. Participants were interviewed about their SODF modification practices, and swallowing difficulties were assessed using the PILL-5 questionnaire. RESULTS: Of 122 participants, 54.1% were aged 60–69, and 9.8% reported dysphagia. SODF modification was practiced by 55.7%. Swallowing problems and pill dysphagia are significantly associated with SODF modification. Among those modifying SODFs, 47.1% incorrectly believed all medications could be safely altered. Splitting tablets was the most common practice (92.6%). CONCLUSION: Both dysphagia and pill dysphagia are significantly associated with SODF modification practices among older patients. Healthcare providers should be vigilant about these practices in older patients with swallowing difficulties. Proper education and assistance in medication handling are essential for this population.

Presence of gluten and soy derived excipients in medicinal products and their implications on allergen safety and labeling

Gluten and soy allergies are significant health concerns, particularly in individuals with celiac disease or soy sensitivity. While dietary sources of these allergens are well-studied, their presence in medicinal products remains under-explored. This study assessed the prevalence of gluten and soy-derived excipients in 308 medicinal products authorized for marketing in Portugal. A systematic search of the Summary of Product Characteristics (SmPC) database was conducted for 108 analgesics and antipyretics containing paracetamol, 85 NSAIDs containing ibuprofen, and 115 antiasthmatic and bronchodilator medicinal products. The study found significant associations between pharmacotherapeutic groups and the presence of these allergens (p < 0.001). Gluten was more prevalent in the group of analgesics and antipyretics (44.4%) than in NSAIDs (8.2%), whereas soy-derived excipients were more frequent in NSAIDs (14%) than in analgesics and antipyretics (6.5%). No excipients containing gluten or soy were identified in antiasthmatic and bronchodilator medicinal products. In analgesics and antipyretics, 51.2% of solid oral dosage forms and 40% of liquid oral formulations contained gluten. Within the NSAIDs group, gluten was mainly present in liquid oral dosage forms (26.7%). Soy-derived excipients were found in 30% of liquid oral formulations and in 33.3% of rectal dosage forms of analgesics and antipyretics. In the NSAIDs group, soy was more prevalent in liquid oral formulations (26.7%). These findings highlight the need for clearer labeling of allergens in medicinal products and underscore the importance of vigilance for patients with gluten or soy allergies. Further research is required to address gaps in allergen disclosure by pharmaceutical manufacturers and to promote safer medicinal product use for sensitive populations. Enhanced awareness among healthcare providers and patients is essential to mitigate the risk of allergic reactions associated with hidden excipients in medicinal products.

Application of a screening tool to understand the medication habits of patients with swallowing difficulty: a prospective observational study.

Difficulty swallowing solid oral dose forms can result in non-adherence and thus can negatively impact patient outcomes. It can be challenging for healthcare professionals to readily identify patients who present with this difficulty within the hospital setting. To apply the "Swallowing Difficulties with Medication Intake and Coping Strategies" (SWAMECO) questionnaire at admission to hospital to elucidate the medication habits of patients when taking medication at home. This prospective observational study took place in acute urban teaching hospital in Ireland in July 2023. Eligible adults completed the SWAMECO, describing their difficulty and the coping strategies used. Data on age, sex, medicines and disease states, as per International Classification of Diseases and Related Health problems (ICD-10) were collected. Self-reported prevalence of swallowing difficulties was 10% (41/409) of whom, 14 patients (median age; 67 years (range 40-86 years), 78.6%; female) completed the SWAMECO. The majority reported having a sensation of medication getting stuck in the pharynx. Swallowing difficulty caused anxiety for some patients and contributed to non-adherence. The most common coping strategy was splitting tablets. Paracetamol was the most frequent solid oral dose form associated with swallowing difficulty and hypertension was the most diagnosed condition. Alternative formulations were available for over half (56%) of the solid oral dose forms prescribed. The SWAMECO can provide valuable information by identification of patients with swallowing difficulty. This may facilitate clinical pharmacist intervention to ensure safe administration of oral medicines and to enhance patient adherence by providing tailored solutions.