Oral Formulations Research Articles

Association between Dental Fear and Children's Oral Health-Related Quality of Life.

This study aimed to examine the association between both parental dental fear and children's dental fear and its impact on the Oral Health-Related Quality of Life (OHRQoL) of Saudi children in the Eastern Province of Saudi Arabia. Data on 93 individuals aged 7-12 years were collected using clinical examination and Arabic-validated questionnaires: the Child Oral Health Impact Profile-Short Form (COHIP-SF19), and the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). Negative binomial regression analysis was performed to study the association between children's fear and parental dental fear as well as the OHRQoL, while adjusting for certain confounders. Overall, our multivariate analyses showed that children with high dental fear (CFSS-DS ≥ 38, p = 0.027) and a higher percentage of dental caries (p = 0.013) had a significantly lower OHRQoL after adjusting for clinical and socio-demographic factors. Further, parental fear of dentists was significantly associated with children's fear of dentists (p < 0.001). Our findings demonstrate that children's fear and dental caries are both associated with poorer OHRQoL. Further, parental dental fear about dentists was associated with children's fear of dentists.

Comparative inhibition by oral bilastine, parenteral dexchlorpheniramine, and a new bilastine parenteral (i.v. and i.m.) formulation of histamine-induced wheal and flare response: A randomised phase I trial

BackgroundBilastine is a well-known non-sedating second-generation antihistamine authorised worldwide for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria with proven efficacy and good safety and tolerability profile. When the oral route is not suitable or a rapid onset of action is preferred, parenteral formulations represent an effective treatment option. However, the parenteral formulations currently available are sedating antihistamines. The objective of this research was to compare the peripheral anti-H1 activity of different bilastine formulations (i.v., i.m. and oral) and dexchlorpheniramine among them also versus placebo. MethodsThis was a single-dose, randomized, crossover, double-blind, placebo-controlled, phase I clinical study performed on 25 adult healthy volunteers that compared the peripheral antihistaminic activity of a single dose of bilastine 12 mg i.v., bilastine 12 mg i.m., bilastine 20 mg oral tablets and dexchlorpheniramine 5 mg i.m. among them and versus placebo by inhibiting the histamine-induced wheal and flare (W&F) response. Pharmacokinetics, safety, and tolerability were also evaluated. ResultsAll bilastine formulations showed a rapid onset of action (15 min for parenteral and 30 min for the oral formulation), and the maximum effect in both wheal (i.v. 74.44 %; i.m.:74.29 %; oral 70,27 %) and flare area reduction (i.v. and i.m. 80.63 %; oral 77.67 %), was significantly larger compared to dexchlorpheniramine i.m. (25.85 % for wheal and 28.65 % for flare) and placebo (1.35 % for wheal and 4.02 % for flare). A more pronounced reduction in itching score was reached for bilastine oral, followed by i.m. and i.v. formulations. No serious adverse events (SAEs) were reported during the study, and 8 treatment-emergent adverse events (TEAEs) were reported by 5 subjects, all resolved without sequelae. For psychomotor assessments, dexchlorpheniramine i.m. showed a fast onset of drowsiness, as well as decreased attention and coordination when compared to all bilastine formulations and placebo. ConclusionsAll bilastine formulations showed a peripheral H1-blocking effect inducing a significantly greater inhibition of the wheal and flare response as compared to dexchlorpheniramine i.m. or placebo and provided a greater reduction of the itching sensation score. This study reconfirmed that bilastine has no sedative effect, even in a parenteral formulation. These results suggest that new bilastine parenteral formulation (i.v. or i.m.) may represent a suitable alternative for patients requiring immediate treatment of histamine-mediated type I hypersensitivity reactions, such as acute urticaria, or in those cases where oral administration is not possible.

The Use of Systemically Absorbed Drugs to Explore An In Vitro Bioequivalence Approach For Comparing Non-Systemically Absorbed Active Pharmaceutical Ingredients in Drug Products For Use in Dogs.

Currently, for veterinary oral formulations containing one or more active pharmaceutical ingredient (API) that are not systemically absorbed and act locally within the gastrointestinal (GI) tract, the use of terminal clinical endpoint bioequivalence (BE) studies is the only option for evaluating product BE. This investigation explored the use of a totality of evidence approach as an alternative to these terminal studies. Three formulations of tablets containing ivermectin plus praziquantel were manufactured to exhibit distinctly different in vitro release characteristics. Because these APIs are highly permeable, plasma drug concentrations served as a biomarker of in vivo dissolution. Tablets were administered to 27 healthy Beagle dogs (3-way crossover) and the rate and extent of exposure of each API for each formulation was compared in a pairwise manner. These results were compared to product relative in vitro dissolution profiles in 3 media. In vivo and in vitro BE predictions were compared. In vivo/in vitro inconsistencies in product relative performance were observed with both compounds when considering product performance across the 3 dissolution media. Formulation comparisons flagged major differences that could explain this outcome. The finding of an inconsistent in vivo/in vitro relationship confirmed that in vitro dissolution alone cannot assure product BE for veterinary locally acting GI products. However, when combined with a comparison of product composition and manufacturing method, this totality of evidence approach can successfully alert scientists to potential therapeutic inequivalence, thereby supporting FDA's efforts to Replace, Reduce, and/or Refine terminal animal studies.

ORENITRAM’s decadal journey: unveiling safety profiles and adverse event through a real-world pharmacovigilance study of FAERS events

ABSTRACT Background ORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring. Research design and methods This retrospective analysis used FDA Adverse Event Reporting System data from Q4 2013 to Q4 2023, employing disproportionality analysis and the reporting odds ratio (ROR) to identify adverse events (AEs) linked with ORENITRAM. Results Out of 15,660,695 reports, ORENITRAM was the primary suspect in 10,125 cases. We identified 174 significant adverse events across 27 organ systems, with notable issues like pulmonary edema, ascites, and ventricular fibrillation. Females reported more AEs (75.6%) than males (24.0%), suggesting potential metabolic differences. AEs were most common within 30 days of starting treatment or after one year. Conclusions The study indicates significant safety issues with ORENITRAM, including serious unexpected events such as pulmonary edema, ascites, and ventricular fibrillation. These findings highlight the necessity for careful clinical monitoring and effective risk management, particularly with observed gender differences in AE profiles. The study’s retrospective nature and reliance on spontaneous reports may affect result generalizability.

Novel pectin-carboxymethylcellulose-based double-layered mucin/chitosan microcomposites successfully protect the next-generation probiotic Akkermansia muciniphila through simulated gastrointestinal transit and alter microbial communities within colonic ex vivo bioreactors

The rapid acceleration of microbiome research has identified many potential Next Generation Probiotics (NGPs). Conventional formulation processing methods are non-compatible, leading to reduced viability and unconfirmed incorporation into intestinal microbial communities; consequently, demand for more bespoke formulation strategies of such NGPs is apparent. In this study, Akkermansia muciniphila (A.muciniphila) as a candidate NGP was investigated for its growth and metabolism properties, based on which a novel microcomposite-based oral formulation was formed. Initially, a chitosan-based microcomposite was coated with mucin to establish a surface culture of A.muciniphila. This was followed by ‘double encapsulation’ with pectin (PEC) using a novel Entrapment Deposition by Prilling method to create core–shell double-encapsulated microcapsules. The formulation of A.muciniphila was verified to require no oxygen-restriction properties, and additionally, biopolymers were selected, including carboxymethylcellulose (CMC), that support and enhance its growth; consequently, a high viability (6 log CFU/g) of A.muciniphila microencapsulated in PEC-CMC double-encapsulates was obtained. Subsequently, the high stability of the PEC-CMC double-encapsulates was verified in simulated gastric fluid, successfully protecting and then releasing the A.muciniphila under intestinal conditions. Finally, employing a model of gastrointestinal transit and faecal-inoculated colonic bioreactors, significant alterations in microbial communities following administration and successful establishment of A.muciniphila were demonstrated.

The Potential Use of Arsenic Trioxide in the Treatment of Systemic Lupus Erythematosus.

Arsenic trioxide (ATO) is now part of the standard regimen for the treatment of newly diagnosed and relapsed acute promyelocytic leukemia. The availability of an oral form of ATO has greatly reduced the incidence of cardiotoxicity as compared to intravenous (IV) administration. Increasing evidence suggests that ATO has anti-inflammatory properties that may be useful for the treatment of autoimmune diseases. These include the modulation of Treg cell activation, Th1/Th2 and Th17/Treg balance, depletion of activated T cells and plasmacytoid dendritic cells, and influence of B-cell differentiation, leading to reduced autoantibody and cytokine production. ATO has also been shown to induce apoptosis of activated fibroblast-like synoviocytes through the generation of reactive oxygen species and alter the gut microbiota in collagen-induced arthritis. Despite the emergence of newer treatment modalities, the treatment of systemic lupus erythematosus (SLE), especially refractory manifestations, remains a challenge, owing to the paucity of effective biological and targeted therapies that are devoid of adverse effects. Oral ATO is an attractive option for the treatment of SLE because of the lower cost of production, convenience of administration, and reduced cardiotoxicity. This article summarizes the anti-inflammatory mechanisms of ATO and its potential application in the treatment of SLE and other rheumatic diseases.

HPLC-DAD method validation for quantification of dehydroabietic acid and abietic acid in oral spray containing Pinus merkusii heartwood extract and its antibacterial effects on clinically isolated Streptococcus mutans

AbstractPinus merkusii Jungh &amp; De Vries. has become increasingly gathered more attention from researchers because the plant has a range of folk medicinal uses. Heartwood plant is the major source of dehydroabietic acid (DHAA) and abietic acid (AA), which possesses several medicinal properties, such as antiviral, antimicrobial, antiobesity and anti-inflammatory. The research proposed herein a low-cost, fast, specific, uncomplicated, sensitive, precise reverse-phase high-performance liquid chromatography (RP-HPLC). This method was conducted and validated for evaluating an amount of DHAA and AA in ethanol extract and oral spray containing P. merkusii heartwood extract. Additionally, stability and antimicrobial activities against clinically isolated Streptococcus mutans of the oral spray were determined. The separation was achieved on Pursuit 200Å PFP column, 150 × 4.6 mm, particles of 3 µm with a flow rate of 1.0 mL min−1. Methanol and water (70:30 v/v) were used as eluent with an isocratic mode and sample analysis volume was set at 10 µL, at a detection wavelength of 210 and 245 nm. The developed HPLC method for analysis of DHAA and AA showed good linearity with correlation coefficients equal to 1. Moreover, other validation parameters, comprised of accuracy, precision, specificity and detection and quantitation limits of this method displayed excellent reliability, validity and sensitivity. This method could be an interesting alternative for quantitative measurement of P. merkusii heartwood extract, oral spray formulation and other P. merkusii heartwood extract preparations. The result from antibacterial tests suggested that the oral spray containing P. merkusii heartwood extract is able to inhibit the oral pathogens causing dental caries. The oral spray decreased S. mutans population size by about 0.5–2 Log CFU mL−1 at 1–4 h and complete elimination of all bacteria strains within 24 h. This study provides validity for using P. merkusii heartwood extract as an alternative for preventing and treating oral infectious diseases.

Physiologically based in vitro – in vivo correlation of modified release oral formulations with non-linear intestinal absorption: A case study using mirabegron

Establishing an in vitro – in vivo correlation (IVIVC) for oral modified release (MR) formulations would make it possible to substitute an in vitro dissolution test for human bioequivalence (BE) studies when changing the formulation or manufacturing methods. However, the number of IVIVC applications and approvals are reportedly low. One of the main reasons for failure to obtain IVIVCs using conventional methodologies may be the lack of consideration of the dissolution and absorption mechanisms of drugs in the physiological environment. In particular, it is difficult to obtain IVIVC using conventional methodologies for drugs with non-linear absorption processes. Therefore, the aim of the present study was to develop a physiologically based biopharmaceutics model (PBBM) that enables Level A IVIVCs for mirabegron MR formulations with non-linear absorption characteristics.Using human pharmacokinetic (PK) data for immediate-release formulations of mirabegron, the luminal drug concentration-dependent membrane permeation coefficient was calculated through curve fitting. The membrane permeation coefficient data were then applied to the human PK data of the MR formulations to estimate the in vivo dissolution rate by curve fitting. It was assumed that in vivo dissolution could be described using a zero-order rate equation. Furthermore, a Levy plot was generated using the estimated in vivo dissolution rate and the in vitro dissolution rate obtained from the literature. Finally, the dissolution rate of the MR formulations from the Levy plot was applied to the PBBM to predict the oral PK of the mirabegron MR formulations.This PB-IVIVC approach successfully generated linear Levy plots with slopes of almost 1.0 for MR formulations with different dose strengths and dissolution rates. The Cmax values of the MR formulations were accurately predicted using this approach, whereas the prediction errors for AUC exceeded the Level A IVIVC criteria. This can be attributed to the incomplete description of colonic absorption in the current PBBM.

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.

Treatment of Acute Sore Throat in Malaysia: A Consensus of Multidisciplinary Recommendations Using Modified Delphi Methodology.

Using antibiotics in the treatment of acute sore throats has been linked with antimicrobial resistance (AMR) and needs to be addressed. The consensus sought to improve diagnostic accuracy, decrease unwarranted antibiotic prescriptions and enhance patient outcomes. A multidisciplinary panel of nine experts reviewed published literature and discussed current practices in managing sore throat. Ten evidence-based statements on sore throat and AMR, diagnostic accuracy and antibiotic prescribing, and symptomatic therapy were developed. A modified Delphi exercise was then carried out. A consensus was reached if at least 70% of the group agreed with the statement. All 10 statements for managing acute sore throat achieved consensus. The major concern of AMR caused by improper antibiotic prescribing, particularly in cases of viral sore throat, was recognized. This underscores the need for improved diagnostic tools, such as the McIsaac score, to reduce needless antibiotic prescriptions. To improve patient satisfaction, effective pain management using non-antibiotic alternatives such as paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), and flurbiprofen throat lozenges was recommended. Pain and inflammation can be adequately managed with low-dose NSAIDs. The potential benefits of topical NSAIDs were acknowledged for their milder safety profile than oral formulations. A consensus was achieved on the use of a clinical diagnostic tool, prudent use of antibiotics, and symptomatic therapy in acute sore throat management. The McIsaac score and point-of-care testing (POCT) for the presence of group A beta-hemolytic Streptococcus (GABHS) can aid in the decision-making process for antibiotic use, reducing needless prescriptions. The mainstay of therapy is symptomatic treatment, which includes the use of NSAIDs.

Bioavailability of a novel sustained-release pellet formulation of 5-flucytosine in healthy-fed participants for use in patients with cryptococcal meningitis.

Cryptococcal meningoencephalitis (CM) is an opportunistic fungal infection and a major cause of death among people living with human immunodeficiency virus in sub-Saharan Africa. 5-flucytosine (5-FC) is a unique, brain-permeable antifungal agent used to reduce mortality from CM and to prevent disease in individuals carrying cryptococcal antigen. 5-FC has a short plasma half-life, requiring 6-hourly oral dosing with an immediate-release (IR) formulation, a significant challenge in hospital and outpatient settings, risking a lack of compliance. We recently reported the relative bioavailability in fasting conditions of a sustained release (SR) oral pellet formulation of 5-FC. In this phase I study, we assessed the safety and pharmacokinetic profiles of the new 5-FC SR formulation in a single dose (2 × 3000 mg), relative to 5-FC IR tablets (Ancotil®; 1500 mg b.i.d.) in healthy participants in fed conditions. This randomized, two-period crossover study was conducted in South Africa to confirm the dose of the identified 5-FC SR formulation for a twice-daily 5-FC regimen in patients. Thirty-six healthy participants were included. All treatments were well tolerated and no serious adverse event was reported. Cmax and AUC(0-t) for the SR formulation (49.2 ± 10.49 μg/mL and 640.4 ± 126.4 h.μg/mL, respectively) were significantly higher than for the IR formulation (36.8 ± 7.61 μg/mL and 456.6 ± 72.8 h.μg/mL, respectively). A physiological based pharmacokinetic model (PBPK) predicted that under fasting conditions, 6000 mg SR pellets would show a good overlap with the IR product (3000 mg b.i.d), thus 6000 mg SR 5-FC b.i.d. in fasting conditions is recommended.

Efficacy and safety of an oral complementary medicine combination in people with symptomatic knee osteoarthritis: Protocol for the double-blind, randomized, placebo-controlled ATLAS trial

ObjectiveTo investigate the efficacy and safety of an oral complementary medicine combination formulation relative to placebo, on changes in pain intensity from baseline to week 12, in people with knee osteoarthritis (OA). DesignA placebo-controlled, double-blind, two-arm, superiority, phase II, Randomized Controlled Trial (RCT) (ACTRN12623000380695). We will recruit 82 participants (∼41 per arm), aged ≥40 years, with a clinical diagnosis of symptomatic knee OA and radiographic change on x-ray (Kellgren-Lawrence Grade ≥2). Participants will be randomly allocated to receive either a complementary medicine formulation containing a daily dose of Boswellia serrata extract (Boswellin® Super, 250 ​mg/day), pine bark extract (Fenoprolic™ 70 Organic 100 ​mg/day), curcumin (500 ​mg/day), piperine (5 ​mg/day), and methylsulfonylmethane (MSM, 1500 ​mg/day), or placebo, for 12-weeks. The primary endpoint will be change from baseline in average knee pain intensity at 12-weeks (visual analogue scale). Secondary endpoints will include change in knee pain from baseline to 12-weeks in the Knee Injury and Osteoarthritis Outcome Score (KOOS), global assessment of disease activity, global rating of change, and health-related quality of life (AQoL-8D). Ethics and disseminationThis protocol has been approved by the University of Sydney Human Research Ethics Committee (#2021/877). Dissemination will occur through lay summaries, infographics, conference abstracts, oral presentations, theses, and scientific publications. ConclusionThis RCT will provide credible evidence about the efficacy and safety of this complementary medicine combination and inform updates to international clinical practice standards on the use of complementary medicines in the management of symptomatic knee OA.

Do we consent to change? An evaluation of oral and maxillofacial outpatient department dentoalveolar consent forms

Obtaining informed consent before performing any dentoalveolar procedure is a professional, ethical, and legal obligation. Prior to this work, in this oral and maxillofacial department, no standardised consent process existed for dentoalveolar procedures. A targeted literature review established localised gold standards for dentoalveolar procedures, and retrospective data from 56 dentoalveolar consent forms over a four-week period assessed baseline compliance with these standards. Data analysis identified that risks of dry socket and trismus were documented in only 7% of cases, and maxillary tuberosity fracture was never documented. Thirty-three per cent of lower third molar cases did not include consent for inferior alveolar nerve injury. Findings were discussed in a departmental audit meeting, and a root cause analysis identified memory failure, repetition fatigue, and varying clinician knowledge and experience, as key drivers. The evidence base and localised gold standards were discussed. A standardised, bilingual, triple-copy dentoalveolar consent form was developed, including predefined indications, additional procedures, and risks, in a tick-box format. This form was presented to the Department of Patient Safety and Quality and gained local approval. Cases completed with the new form will now be evaluated against the localised gold standards, with a mixed-methods feedback survey investigating staff and patient opinions. Local processes for obtaining and documenting valid consent for dentoalveolar treatment were found to be inconsistent and frequently inadequate. Fifteen localised gold standards were set, and a new standardised consent form developed, which will be evaluated for effectiveness and acceptability.

Assessment of oral health status amongst postal employees of Bhubaneswar city: A cross-sectional study.

Upholding good dental health has wider effects on productivity and performance at work in addition to being crucial for individual well-being. Because it can affect both their personal well-being and productivity at work, post office workers' oral health is therefore a critical issue of concern. Hence, evaluating Bhubaneswar city post office workers' dental health is the study's aim. With the aid of the WHO 2013 oral health assessment form, a cross-sectional study involving 171 regular post office workers was undertaken. Using the Chi-square test and an ANOVA for pertinent variables, the data were analysed using SPSS statistical software version 27.0. Potential confounding variables were adjusted using multiple logistic regression analysis. The survey included a total of 171 post office personnel, of which 76.6% were men and 23.4% were women. The participants' periodontal health revealed that 67.7% had deep periodontal pockets, 18.7% had shallow ones, and 95.3% had bleeding gums. The mean DMFT of the study participants was 4.10 ± 3.149. Among post office workers, tobacco use and oral health conditions represent a crucial junction of variables that call for caution and preventative action.

Formulation, Design, Optimization, and Characterization of Novel Long-acting Injectable Dosage Form of Anti-psychotic Drug

Background: The current research aimed to create and analyze a new long-acting Brexpiprazole (BRX) injectable for successful anti-psychotic drug therapy in order to decrease dosage frequency and increase patient compliance. Systems for drug transport to particular body sites or regulating release rates with accuracy are known as drug delivery systems (DDS). By affixing the drug to a carrier particle like liposomes, nanoparticles, microspheres, etc., which modifies the drug's absorption and release properties, using carrier technology, drugs may be delivered in an intelligent manner. Methods: Utilizing Resomer RG 502 H and RESOMER® RG 752 H extended-release Polymer, Using a quasi-emulsion solvent diffusion, microspheres were made, and emulsification and solvent evaporation process. Results: The produced microspheres were assessed for stability tests, in vitro drug release, flow characteristics, and drug entrapment efficiency. FTIR experiments were used to establish how well the drug excipients worked together. The acarbose microspheres that were created had an 89.9 to 96.1 percent drug entrapment efficiency. The impact of factors like polymer content on medication release was studied. The Stability study of the formulation was carried out under different conditions, and data were established. Comparative pharmacokinetic studies between marketed oral formulation and Brexpirazole microsphere test formulations in Wistar/SD Rats were carried out and concluded. Conclusion: Brexpiprazole (BRX) novel long-acting injectable formulation, could be used effectively for the treatment of mentally challenged anti-psychotic patients worldwide.

GLP-1 Receptor Agonists - An Anaesthesiologist’s Perspective – A Comprehensive Review

GLP-1 receptor agonists help in regulating blood sugar levels and encouraging weight reduction in individuals with non-insulin-dependent diabetes mellitus who adhere to dietary guidelines and exercise regularly. Semaglutide is a commonly utilized type of GLP-1 receptor agonist. The injection is usually administered once every seven days subcutaneously, beginning at 0.25 mg, with the highest weekly dosage is between 2.0 and 2.4 mg (larger doses are employed to promote weight loss instead of regulating blood sugar). Semaglutide’s half-life is approximately one week, indicating it remains active in the body for a long duration. So, it requires roughly five weeks to reach its stable level in the body, and it also takes the same amount of time for its effects to cease after discontinuation. There is now an oral formulation, and its effects might resemble those of the injection (1,2)

Preparation and Evaluation of Medicated Oral Jelly

Developed in the 20th century, oral medicinal jellies are still produced commercially and are still well-liked by customers. These are chewable solid dose forms that dissolve in the mouth or throat to provide either localized or systemic effects. They are taken orally. As a pharmacological composition, oral medicated jelly has some benefits but also certain drawbacks. They can be applied to the buccal, labial, gingival, and sublingual channels of drug administration, among other routes. These jellies, which come in flavors including chocolate, strawberry, pineapple, and mango, are over-the-counter drugs. They comprise medications for a number of ailments, including sore throat, antistatic, erectile dysfunction, arthritis, and hypertension. The Japanese Ministry of Health, Labour, and Welfare authorized a once-weekly oral program in 2012 The world's first medication for osteoporosis in a jelly formulation was approved by the Japanese Ministry of Health, Labour and Welfare and is to be taken orally once a week. A process of heating and congealing is used in their formulation. Oral medicated jellies serve as a new dosage form with vast uses in pharmaceuticals, nutraceuticals, and over-the-counter drugs. This study offers formulation scientists insight into new uses for this drug delivery technology by focusing on several facets of oral medicated jelly formulation. Orodispersible dose formulations provide patients additional possibilities for medication administration. They are simple to use and don't need ingesting big, solid dose forms or consuming a lot of water. This research aims to develop and assess the mouth-dissolving film of lisinopril as an ACE inhibitor for the treatment of congestive heart failure and hypertension. When compared to traditional solid oral dose forms, these forms are thought to increase the bioavailability of medications.

Efficacy and Safety in a Real-World Study of the New Oral Formulation of Semaglutide in Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus.

Background/Objectives: GLP-1 receptor agonists (GLP-1RAs) have emerged as fundamental components in the treatment of type 2 diabetic patients (T2DM) with chronic kidney disease (CKD). The oral formulation represents a novel therapeutic tool but may affect drug efficacy. This study sought to compare the effectiveness of subcutaneous versus oral semaglutide formulations in patients with CKD. Methods: A retrospective study in a real-world setting compared type 2 diabetes and chronic kidney disease patients, initiating oral semaglutide treatment to a historically matched control group treated with subcutaneous semaglutide. The matching considered factors such as estimated glomerular filtration rate (eGFR), age, and sex. Results: Nineteen patients were included in both groups, with a mean age of 68.0. Seventy-two percent were males with a CKD-EPI eGFR of 49.9 mL/min/1.73 m2 and a median urine albumin-to-creatinine ratio of 12.7 mg/g. Of the study participants, 94% and 79% of patients were on the maximum semaglutide sbc vs. oral dose, while 5.3% and 15.8% were on the sbc vs. oral low dose. Oral semaglutide significantly reduced HbA1C and BMI, identical to the control group (-0.9 and -1.4, p > 0.05). Renal function parameters and blood pressure remained stable throughout the follow-up in both groups. The main side effect was digestive intolerance (affecting three patients in the oral group and two patients in the subcutaneous group, p = 0.6), although the treatment abandonment percentage was similar. Conclusions: The oral formulation of semaglutide demonstrated equivalent effectiveness in glucose control and body weight management in patients with T2DM and CKD, even with a higher proportion of patients receiving low to medium doses. Gastrointestinal side effects were comparable between both oral and subcutaneous formulations.

Cyclodextrin-Polymethylsilsesquioxane Combined System as a Perspective Iron Delivery System for Oral Administration.

Anemia is a global health problem that affects both adults and children, but treatment is hampered by serious side effects, primarily associated with the gastrointestinal tract with oral administration of drugs. In this study, we aimed to develop an oral form of iron compounds using polymethylsilsesquioxane hydrogels. To boost loading efficiency and prolong release, the iron compounds (FeCl3 and ferrous D-Gluconate) are incorporated into a guest-host complex with 2-hydroxypropyl-beta-cyclodextrin. We used PRXD, SEM, EDX mapping, and FTIR to investigate the complex formation, as well as the incorporation of such complexes into hydrogels. The optimal system underlines a combination of ferrous D-Gluconate and HPCD in a 1:1 molar ratio, embedded into a hydrogel with a modest quantity of silicate crosslinks. We demonstrated the slowing of iron release in a gastric media. Mathematical investigation revealed that the Higuchi mechanism releases iron from the hydrogel.

Patient and clinic staff perspectives on the implementation of a long-acting injectable antiretroviral therapy program in an urban safety-net health system

BackgroundLong-acting injectable cabotegravir plus rilpivirine (LAI CAB/RPV) has several potential benefits over daily oral formulations for HIV treatment, including the potential to facilitate long-term adherence and reduce pill fatigue. We aimed to assess facilitators of and barriers to LAI CAB/RPV implementation and delivery through the perspectives of physicians and clinical staff, and the experiences of LAI CAB/RPV use among people living with HIV (PLWH) at a Ryan-White supported safety-net clinic in North Texas.MethodsWe conducted semi-structured interviews with recruited clinic staff (physicians, nurses, and support staff) involved with LAI CAB/RPV implementation and PLWH who switched to LAI CAB/RPV and consented to participate in individual interviews. Data were collected from July to October 2023. Our interview guide was informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM), and Proctor Implementation Outcomes frameworks. Qualitative data were analyzed using a rapid qualitative analysis approach to summarize key themes.ResultsWe recruited and interviewed 15 PLWH who transitioned to LAI CAB/RPV and 11 clinic staff serving these patients. PLWH conveyed that emotional and informational support from family or a trusted clinician influenced their decision to switch to LAI CAB/RPV. PLWH also reported that injectable treatment was more effective, convenient, and acceptable than oral antiretroviral therapy. Clinic staff and physicians reported that staff training, pharmacist-led medication switches, flexible appointments, refrigeration space and designated room for injection delivery facilitated implementation. Clinic staff cited medication costs, understaffing, insurance prior authorization requirements, and lack of medication access through state drug assistance programs as critical barriers.ConclusionsOur study offers insights into real-world experiences with LAI usage from the patient perspective and identifies potential strategies to promote LAI CAB/RPV uptake. The barriers to and facilitators of LAI CAB/RPV program implementation reported by clinic staff in our study may be useful for informing strategies to optimize LAI CAB/RPV programs.