Oral Liquid Dosage Forms Research Articles

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.

A validated stability‐indicating reversed‐phase‐UPLC method for simultaneous estimation of promethazine hydrochloride, methylparaben, propylparaben and sodium benzoate assay of cough suppressant and antihistamine liquid oral dosage forms

A quick, simple, sensitive, efficient and stability-indicating reverse-phase ultraperformance liquid chromatographic method for the estimation of propylparaben, methylparaben and sodium benzoate in a pharmaceutical liquid oral formulation was developed. A Waters Acquity UPLC BEH C18, 50 × 2.1 mm, 1.7 μm i.d. column was used to perform chromatographic separation with a 0.1% perchloric acid mobile phase used as solvent A and a mixture of 0.1 % perchloric acid and methanol in the ratio 20:80 (v/v), respectively, as solvent B. The experiments were carried out at a flow rate of 0.4 ml/min and the detection wavelength was 240 nm. The compartment temperature of the column was set at 40°C and the injection volume was set at 2 μl. The main aim of the research was to develop a single UPLC assay method for promethazine (active ingredient) and preservatives in the oral solution of promethazine HCl and dextromethorphan HBr that contains promethazine (active ingredient) and methylparaben, propylparaben and sodium benzoate (preservatives). An assay of dextromethorphan HBr was developed and validated by another HPLC method. The drug and preservatives were eluted at retention times of 19.3 min for promethazine HCl, 9.3 min for methylparaben, 18.9 min for propylparaben and 8.9 min for sodium benzoate. Validation of the developed method was carried out as stated by the International Conference on Harmonization guidelines ICH Q2B and under USP<1225>. The analytical parameters verified specificity/selectivity, linearity, accuracy, ruggedness and robustness. The linearity ranges of promethazine HCL, methylparaben, propylparaben and sodium benzoate were 10-100, 10-80, 1.0-8.0 and 10-80 μg/ml, respectively, with a correlation coefficient of active ingredients and preservatives of 1.00. Percentage recoveries of promethazine, propylparaben, methylparaben, and sodium benzoate were 100.0-100.2, 99.0-100.3, 99.5-98.0 and 99.0-100.0%. The validated analytical method proves that the method is specific, precise, linear, accurate, sensitive, rugged and stable, indicating the quantification of the active ingredient and all preservatives in liquid oral formulations.

PREPARATION AND EVALUATION OF LAFUTIDINE NANOEMULSION AS ORAL DELIVERY SYSTEM

Objective: Lafutidine is a histamine (H2) receptor antagonist utilized for the treatment of gastric ulcer. Its oral bioavailability is low due to poor water solubility and an extensive first-pass hepatic. So, the present work aims to formulate and characterize of an oil in water (o/w) nanoemulsion of lafutidine as oral liquid dosage form and this could enhance drug solubility and improve its bioavailability. Methods: The pseudo-ternary phase diagrams were constructed via titration method. The diagram plots derived from oil, various ratios of surfactant and co-surfactant (S mix), and double distilled water. The selected optimized lafutidine nanoemulsions formula was determined via a variety of investigational studies like particle size, polydispersity index (PDI), zeta potential, pH, drug content and an in vitro drug release. Results: Characterization studies revealed that the optimum formula of nanoemulsions was (NE5), which consist of 0.2% of lafutidine, 30 % of surfactant and co-surfactant (S mix) (3:1), which mean (22.5%of tween 20:7.5% of polyethylene glycol 200 (PEG 200), 10% of peppermint oil and 59.4% of double distilled water. The optimized formula exhibited droplets size (62.56-96.2 nm), PDI (0.11), good pH value (7.1), zeta potential (-32.2 mV), high drug content (99.2%), in vitro release of lafutidine was significantly higher (P&lt;0.05) for NE5. Scanning probe microscopy (SPM) revealed that the droplets size of NE5 was in nano-scale. Conclusion: It is possible to conclude that the optimized formula (NE5) was promised formula of nanoemulsion for increasing the orally delivered lafutidine bioavailability.

AN OVERVIEW ON THE PHARMACOLOGICAL ACTIVITIES OF SHARBAT-E-UNNAB

Sharbat is a significant oral liquid Unani dosage form. The primary advantage of preparing pharmaceuticals using sharbat is preserving them and preventing putrefaction and fermentation since they are done with sugar or honey. Sharbat-e-Unnab is a sweet-tasting liquid dosage form made from the decoction of Ziziphus jujuba fruit. It has been used for a long time in the treatment of skin diseases such as, Nar-Farsi (eczema), Urticaria and Blood heat suppression (Musakkin-e-Hiddat-e-khoon), Musaffi-e-khoon (Blood purifier) and Daf-e-ufoonat (Antiseptic). The major component of Sharbat-eUnnab is Ziziphus jujuba fruit, which has carbohydrates, proteins, vitamins, and minerals. Polysaccharides, Alkaloids, Glycosides, Flavonoids, Ternoids, and Vitamin C are among its phytochemical ingredients. Studies on its pharmacological properties revealed effects that included Wound healing, Immunomodulatory, Anti-inflammatory, Anti-cancerous Antiallergic and Antioxidant properties.

Stability indicating reversed-phase-high-performance liquid chromatography method development and validation for pyridostigmine bromide and sodium benzoate in oral solution.

The present study focuses on the development of a simple, rapid, specific, and stability-indicating HPLC method for the simultaneous analysis of pyridostigmine bromide (PGB) and sodium benzoate (SBN) in oral liquid dosage forms. Analytical techniques should enhance sensitivity and specificity for the estimation of pharmaceutical drug products. Stress studies were conducted under various International Conference on Harmonization (ICH) conditions for evaluation. The further optimized HPLC method was validated in accordance with the current ICH guidelines. Chromatographic separation was accomplished using a mobile phase consisting of a 950:50 v/v ratio of perchloric acid buffer and acetonitrile as mobile phase-A, and 100% acetonitrile as mobile phase-B. The flow rate is 1.0 mL/min, and the injection volume is 20 μL. Detection of components was carried out at 220 nm for PGB and 228 nm for SBN. The validated HPLC method demonstrated high specificity, with linearity ranging between 24 and 72 μg/mL for PGB and 5.2-15.6 μg/mL for SBN. The correlation coefficient for both drugs exceeded 0.999. The method demonstrated high accuracy, exceeding 97%. In stress studies, PGB was found to be sensitive to alkaline stress conditions. The results reveal the successful applicability of the current method for the estimation of PGB and SBN in its marketed formulation, which can be reasonably inferred to assess other formulation systems.

Quality of measuring devices enclosed with paediatric oral liquid dosage forms of medicines registered in Sri Lanka.

Oral liquid dosage forms remain popular in several middle income countries. The accuracy of liquid dosage form dosing depends on the accuracy and availability of measuring devices. Lack of quality oral liquid measuring devices will lead to medication errors. Hence there is an urgent need to describe the quality of manufacturer supplied measuring devices enclosed with paediatric oral liquid dosage forms currently registered in Sri Lanka. Standards for measuring devices were developed after a detailed literature search. Multidisciplinary panel rated each standard for the necessity criteria on a 9 point Likert scale. Standards with overall panel median score of ≥ 7 with agreement were selected. A cross-sectional study was done. All the measuring devices, labels and instructions enclosed with the registered products were assessed against the standards developed. Three volumes of liquid antibacterials were measured using the enclosed measuring device. Accuracy of the volumes was measured. Of the total products (n = 202) only 126 were packed with a dosing device. Around quarter of the oral liquid dosage forms (n = 36) did not have a measuring device. More than half of the measuring devices aligned with all the standards developed. Out of 44 oral liquid paediatric antimicrobials measuring cups (n = 25, 56.8%, 95% CI: 41%-72%) were enclosed more and less error was seen with measuring cups. The quality of oral liquid measuring devices were not satisfactory. Quality could be further improved if the regulatory body request the manufactures/importers to adhere to the standards developed. Correct volumes were not measured using the measuring devices provided with the liquid antimicrobial agents.

Rapid screening and multicomponent quantifications of active components of oral syrup over-the-counter medications by Raman and UV–visible spectroscopy and multivariate regression analysis

Over-the-counter medications (OTCMs) are frequently recommended as a first-line treatment for common ailments, diseases, and illnesses. Oral liquid dosage forms are advantageous for rapid absorption with no dissolution time and are easier for pediatric and geriatric consumers to swallow. The production of these medicines by pharmaceutical industry makes them readily available to the public. Although the US Food and Drug Administration (FDA) provides strict guidelines to drug manufacturers of these products; the risk of counterfeiting is a global issue. This can lead to several adverse effects and health issues. Here, we report a fast screening and quality assurance method using Raman and UV–visible spectroscopy combined with Principal Component Analysis (PCA) and Partial-Least-Square (PLS) regression of commonly used OTCM oral syrups. PLS regressions of UV–visible absorption spectra were used for multicomponent quantifications of the active component (acetaminophen, guaifenesin, dextromethorphan HBr, and phenylephrine HCl) concentrations of OTMCs in flavored (sugar or sugar-free) oral syrups. Raman and UV–visible spectral responses varied based on the type and concentration of the active component analyzed. PCA of the spectral data provided pattern recognition of the oral syrup OTCM. The developed PLS method demonstrated good linearity with an R2 > 0.9784 and high sensitivity with a low detection limit of 0.02 mg/mL for acetaminophen and guaifenesin. Moreover, the simultaneous quantification of concentrations of all active components by the described method yielded good accuracies ranging from 88 to 94%. This study provides an example of the benefits of the combined use of Raman and UV–vis spectral profiling, PCA, and PLS regression for the quality analysis of oral syrups OTCM providing multicomponent quantification of active components with no need for sample extraction. The reported method can be easily adapted and scaled for online detection analysis used in the drug manufacturing industry, both in-situ and field analysis, and for the quality control of syrups OTCM by regulatory agencies and quality control officers.

PREPARATION AND OPTIMIZATION OF CILOSTAZOL NANOEMULSION ORAL LIQUID DOSAGE FORM

Objective: Cilostazol has poor water solubility and low oral bioavailability. Therefore, the formulation of cilostazol as a nanoemulsion may enhance its solubility and improve oral bioavailability. Hence, the aim of this study was to formulate and characterize an oil-in-water (o/w) nanoemulsion of cilostazol as an oral liquid dosage form. Methods: Pseudo-ternary phase diagrams were constructed using the aqueous titration method. Formulations of pseudo-ternary phase plots consisting of oil, various weight ratios of S mix (mixture of surfactant and co-surfactant), and deionized water were made. Different characterization studies, droplet size measurement, polydispersity index, drug content, zeta potential measurement, and in vitro release have been conducted to choose the optimized formula. Results: The characterization studies have demonstrated that the optimized formula is (F-6), consisting of 20 % S mix (3:1), 10% ginger oil, and 70% deionized water. This formula had the following characteristics; droplet size (72.9-110 nm), polydispersity index (0.22), percentage of drug content (99.8%), and in vitro release of cilostazol nanoemulsion was significantly higher (P&lt;0.05) in comparison with other formulations. A Scanning probe microscopy (SPM) study has revealed that the droplet size of F-6 was at the nano-scale. Conclusion: In conclusion, the optimized cilostazol formula (F-6) is a promising formula which may have the capability of improving the oral bioavailability of cilostazol.

Insights into the formulation properties, biocompatibility, and permeability of poorly water-soluble methoxyflavones with PEG400 and propylene glycol.

Herein, thermal and non-thermal techniques were used to elucidate the putative physical and chemical interactions between poorly water-soluble Kaempferia methoxyflavones and PEG400/propylene glycol. Additionally, the biocompatibility of methoxyflavone-glycol solutions was evaluated using Caco-2 cells whereas the absorptive transport was investigated by measuring the apparent permeability coefficient (P app) of the methoxyflavones and transepithelial electrical resistance (TEER) of the Caco-2 cell monolayer. Data from differential scanning calorimetry, Fourier-transform infrared (FTIR), and proton nuclear magnetic resonance (1H NMR) spectroscopic analysis revealed physico-chemical compatibility between the three methoxyflavones and PEG400/propylene glycol. Furthermore, PEG400 and propylene glycol solutions of the methoxyflavones were shown to be compatible with Caco-2 cells at pharmacologically effective concentrations. In vitro transport studies across the Caco-2 cell monolayer revealed high P app values of 24.07 × 10-6 to 19.63 × 10-6 cm s-1 for PEG400 solutions of the methoxyflavones. The TEER values of the Caco-2 cell monolayers indicated that the increased drug transport was partly due to increased tight junction openings, but without compromising the epithelial barrier integrity. The good pharmaceutical and biocompatibility profiles, as well as improved transport of the methoxyflavones in PEG400 and propylene glycol solutions, are suggestive of the worthiness of this approach for further consideration pertaining to the development of these drugs into oral liquid dosage forms.

Development of solid lipid nanoparticles of diacerein in a stable oral liquid dosage form using a central composite design

Diacerein (DCN) is used mainly to treat degenerative diseases, such as osteoarthritis. DCN is marketed commercially in solid dosage forms. Liquid formulations of diacerein (DCN) have been hindered by its poor chemical stability in aqueous media. This work aims to develop a novel, stable, oral, liquid preparation of DCN having a concentration of 50 mg/5 ml. Solid lipid nanoparticles (SLNs) of DCN were prepared using cetyl alcohol as the lipid matrix and Tween 80® as a surfactant. A quality-by-design approach was utilized to optimize DCN-SLNs. The optimum DCN-SLNs were dispersed in a structured vehicle to formulate the liquid dosage form. This liquid preparation was subjected to accelerated stability studies at 40 °C and 75% RH for 6 months. The potential of the liquid preparation to minimize the diarrheal effect of DCN was assessed. Optimum concentrations of cetyl alcohol (2%) and Tween 80® (0.9%) were chosen to obtain the desired characteristics of SLNs. Interestingly, we determined that 0.05% of citric acid was the maximum concentration that can be added to the liquid preparation of diacerein to modify its pH without compromising its stability. The results of the stability studies show that the liquid preparation was robust and it withstood storage conditions (40 °C, 75% RH) for 6 months. The encapsulation of diacerein helps to protect it from degradation and significantly reduced the occurrence of diarrhea as a side effect (p < 0.0001). Liquid preparations of DCN-SLNs can thus be marketed as a new dosage form.

Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient's Safety-A Narrative Review.

The development of safe and effective pediatric formulations is essential, especially in therapeutic areas such as pediatric cardiology, where the treatment requires multiple dosing or outpatient care. Although liquid oral dosage forms are considered the formulation of choice given the dose flexibility and acceptability, the compounding practices are not endorsed by the health authorities, and achieving stability can be problematic. The purpose of this study is to provide a comprehensive overview of the stability of liquid oral dosage forms used in pediatric cardiology. An extensive review of the literature has been performed, with a particular focus on cardiovascular pharmacotherapy, by consulting the current studies indexed in PubMed, ScienceDirect, PLoS One, and Google Scholar databases. Regulations and guidelines have been considered against the studies found in the literature. Overall, the stability study is well-designed, and the critical quality attributes (CQAs) have been selected for testing. Several approaches have been identified as innovative in order to optimize stability, but opportunities to improve have been also identified, such as in-use studies and achieving dose standardization. Consequently, the information gathering and the results of the studies can be translated into clinical practice in order to achieve the desired stability of liquid oral dosage forms.

Correct administration aid for oral liquid medicines: Is a household spoon the right choice?

Correct medicine dosing is an important component in the safe and effective delivery of medicines, particularly for the pediatric population. However, there is a scarcity of public campaigns on the correct administration and choice of dosing aids for oral liquid dosage form in many countries, leading to medicine safety issues and therapeutic failures. The study targeted the assessment of the knowledge and practice of university students. It utilizes pre- and post-intervention surveys administered through google forms as a survey tool during online zoom and in-person sessions. The intervention included a short video presentation detailing the selection and use of medicine spoons and other aids for the administration of oral liquid dosage. The Fischer Exact test was used to assess the pre- and post-test shift of responses. Nine-degree programs were engaged in the activity, and 108 students attended this health awareness activity after obtaining formal consent. A significant decline (CI = 95%, **** p-value < 0.05) in the choice of selecting tablespoon and a shift to a low-volume spoon, as well as rejection of an entire variety of household spoons, were observed. A significant improvement in the correct naming of spoons, the meaning of the abbreviation "tsp," and the correct volume of a standard teaspoon were also observed with a p-value of <0.001. A deficit in the knowledge of the proper use of measuring devices for oral liquid medicines in the educated population was observed, which can be enhanced through simple tools like short video presentations and awareness seminars.

Formulation and development of Oral herbal liquid dosage form with its quality evaluation parameters

The present work deals with the formulation and development of oral herbal liquid dosage and its comparative study with marketed dosage for quality evaluation parameters. We have used different Poly-herbs for the formulation of syrup because they expressed high effectiveness in a vast number of diseases. As aforementioned the therapeutic effect of herbal medicines is exerted due to the presence of different constituents and the effects are further potentiated when compatible herbals are formulated together in PHFs (Poly-herbal formulations). PHF show compatible effect with those of standard allopathic drugs. We had tested its Quality control pre and post-formulation evaluation parameters. The Quality control tests for developed herbal syrup include: Physical appearance (Color, Odor, and Taste), Clarity tests, solubility tests, pH, Density, Viscosity, Specific gravity, Refractive index, FTIR study of active constituent used in herbal syrup. This syrup is also tested for acute oral toxicity study (LD50), Antioxidant activity by using Nitric oxide free radical scavenging method, and hepato-protective activity by using paracetamol-induced hepatotoxicity in rats. From the obtained results, we concluded that formulated poly-herbal syrup passed all quality control tests and also proved its effectiveness. The formulation F2 and F3 were the best poly-herbal formulation and it was selected for further study. In hepato-protective activity, F2 formulation when compared with the standard formulation of silymarin have shown good results.

Compounded medications for cardiovascular use in neonatology: an integrative review.

ABSTRACTObjective:To analyze the profile of the compounded cardiovascular medicines prescribed in neonatology in Brazil.Data source:An integrative bibliographic review was carried out, including studies published in the last 20 years. The used descriptors were: Intensive Care Neonatal, Off-Label Use, Pharmaceutical Preparations, in the databases Virtual Health Library (VHL), PubMed, and Scientific Electronic Library Online (SciELO). Review articles and guidelines were excluded. The quality of the evidence was analyzed, and 10 articles were selected to integrate the study.Data synthesis:The profile of routine prescrption in the neonatal unit was evaluated. The main cardiovascular medications prescribed as compounding formulation were: Spironolactone, Captopril, Furosemide, Hydrochlorothiazide, Propranolol, Amiodarone, Nifedipine, Carvedilol, Digoxin, Enalapril, Epinephrine, and Hydralazine. The drugs were obtained from adaptations of dosage forms, through the transformation of capsules or tablets into liquid formulations, as a solution, suspension, or syrup, as well as in the form of solutions prepared from active pharmaceutical ingredients. The compounding of medications made drug therapy possible in neonatology, considering that such medications do not have registration of the oral liquid dosage form in the country, despite being part of the List of Essential Medicines for Children of the Word Health Organization.Conclusions:It was possible to analyze the profile of compounded cardiovascular medicines prescribed in neonatology in Brazil. The results showed the need for the development of medications suitable for the neonatal population, and the standardization of operational procedures for preparing extemporaneous formulations in neonatology to increase drug safety.

Formulation Development and Evaluation of Desloratadine Sugar Free Oral Liquid Dosage Form

The aim of the present work is to formulate and evaluate Desloratadine Sugar free oral liquid dosage form. Desloratadine is an anti-histamine drug which is used to treat allergic reactions such as chronic utricaria, watery eyes and runny nose. In this Present work Desloratadine sugar free oral liquid dosage form was formulated by using artificial sweeteners with the help of simple mixing technique and subjected to various evaluation tests. The Pre-formulation studies like identification of pure drug by melting point method, solubility, Drug-Excipients compatibility studies by FTIR studies were evaluated. Post formulation studies like oranganoleptic properties, Physico-chemical properties, Assay, Related substances and Microbial examination were evaluated. Organoleptic property has shown that the all formulations was found to be clear orange and complies with innovator. Assay of Desloratadine and sodium benzoate of all six formulations F1, F2, F3, F4, F5, and F6 were determined and found to be 99.1%, 99.8%, 100.1%, 100.2%, 100.1% and 99.9% respectively. Related substances of all the formulations were determined and the impurities A and B were found to be within the limits and there is no any unspecified impurity. Microbial examinations of all the formulations are determined and the total bacterial count and fungal count are within the limits and E.coli is absent. The formulation of Desloratadine sugar free oral liquid dosage form by using artificial sweeteners was Developed and evaluated.

Formulation and Evaluation of Naproxen Orodispersible Tablets

Background: In the treatment of variant disease, oral administration is the main choice in society, especially in children. Orodispersible tablets have been more popular among children in recent years than oral liquid dosage forms. An Orodispersible tablet disintegrates in the oral cavity and the drug gives pharmacological and therapeutically responses as the faster onset of action. &#x0D; Purpose of the study: Naproxen is a nonsteroidal anti-inflammatory drug that is used to treat mild to moderate pain and arthritis. In this study, super disintegrant agents Crospovidone and Croscarmellose Sodium were used to make Naproxen orodispersible tablets utilizing a direct compression approach. &#x0D; Research rationale: The goal of this study was to develop and evaluate orodispersible naproxen tablets in order to improve their disintegration and dissolving profiles.&#x0D; Method: Direct compression techniques were used to manufacture naproxen orodispersible tablets, which disintegrate in the oral cavity without the need for water in a matter of seconds when placed on the tongue.&#x0D; Results: FTIR and PXRD were used to investigate the drug-excipient interaction. The pre-compression and post-compression properties of the prepared tablets were assessed. The formulated tablets show a disintegration time of 32-53 seconds with In vitro drug release of 100% within 15 minutes. Weight variation, Friability, and Hardness were all found to be within acceptable limits. &#x0D; Conclusions: Naproxen orodispersible tablets containing croscarmellose sodium, crospovidone, and other excipients provide improved disintegration and a more complete drug release profile.

Following drug degradation and consequent taste deterioration of an oral reconstituted paediatric suspension during dosing interval via electronic tongue

BackgroundThe taste of oral liquid dosage forms is a crucial factor that impacts pediatric patient compliance. Taste of suspensions can be typically evaluated by human volunteers. Recently, the electronic tongue (ET) has been proven as an emerging tool that could be useful to follow up various formulations’ properties like taste and composition. This study aimed to evaluate the potential use of ET in assessing the taste deterioration of reconstituted oral suspensions and compare the results obtained with the typical in vivo panel taste method. MethodsFour commercially available brands of amoxicillin/ clavulanic acid suspensions (one brand and three generic formulations) were reconstituted and stored in refrigerator to assess their taste on a daily basis. The taste of these products was assessed using Alpha-Astree ET and the obtained results were compared with those obtained from an in vivo panel taste assessment using a hedonic panel test (the 5-point hedonic scale). ResultsAll evaluated suspensions exhibited similar trends. ET and in vivo analysis indicated low taste scores for all evaluated suspensions immediately after reconstitution, possibly due to the incomplete dissolution of sucrose. The scores for all formulations were higher on day 2, followed by a steady state for the next two days. After that, a significant decay in the scores was observed in the fifth day for all evaluated suspensions. ET results were in excellent agreement with the results obtained via in vivo panel test method. ConclusionThe ET seems to be promising for testing the taste of pharmaceutical liquid preparations and evaluate possible deterioration upon storage or after reconstitution. It may provide a platform to avoid the involvement of pediatric volunteers in clinical evaluation and can be employed as a quality control tool during manufacturing.

Formulation and evaluation of floating bilayer tablets of epleronone

Gastro retentive drug delivery systems have been widely used to prolong retention of dosage forms in stomach. Among the various approaches, the floating bilayer tablets formulation offers sustained drug release as well as prolonged gastric retention, along with the added advantage of liquid oral dosage form. The present study was an attempt to formulate and evaluate floating bilayer tablets of Epleronone by using various polymers like guar gum, ethyl cellulose, SSG, CCS. The prepared floating Bilayered tablets were evaluated for hardness, Weight variation, thickness, friability, drug content uniformity, and in-vitro dissolution studies. Based on various evaluation parameters formulation F3 (IR) &amp; F12 (SR) was selected as optimized formulation. From the above floating buoyancy studies shows that F12 shows higher Total floating time than other formulations. It was observed that Formulations F3 (IR) &amp; F12 (SR) gave maximum drug release within time. All formulations were subjected for drug release kinetics studies viz. Zero order, first order, Higuchi matrix, Peppas model equations and the formulations of sustained release (SR) formulations followed zero order release with non-fickian diffusion mechanism.

Formulation and Pharmaceutical Assessment of Annona muricata Oral Capsules and Suspension as Antidiarrhea Dosage Forms

Annona muricata (Annonaceae) is a tropical plant widely known for its edible fruits. Recent scientific studies have confirmed the folkloric use of its seeds as an antidiarrheal agent. This study sought to formulate capsules and suspensions using the ethanolic extract from Annona muricata seeds. The dried ethanolic extract was formulated into granules and subsequently encapsulated. The suspension formulated was assessed for sedimentation rate, sedimentation volume, viscosity, dissolution, drug content, and flow rate, while pharmacopeia tests such as disintegration, dissolution, uniformity of weight, and drug content were carried out on the formulated capsules. The formulated suspension passed the drug content and in vitro release studies. Annona muricata suspension exhibited pseudoplastic flow with good sedimentation rate and sedimentation volume. The formulated capsules passed the in vitro dissolution studies, weight uniformity, disintegration, and drug content tests. The ethanolic extract of Annona muricata seeds was appropriately formulated into standardized solid and liquid oral dosage forms.

Formulation and In Vitro Evaluation of Oral Capsules and Suspension from the Ethanolic Extract of Cola nitida Seeds for the Treatment of Diarrhea.

Management of diarrhea has evolved over the years from relatively inadequate interventions in the early years to more successful physiological approaches. The use of herbal medicinal products and supplements has grown significantly over the past three decades, with more than half of the global population depending on it for some aspect of their primary health care needs. This study is aimed at formulating solid and liquid oral dosage forms of the ethanolic extract of Cola nitida seeds for the treatment of diarrhea. The flow property of the dried ethanolic extract was determined and subsequently formulated into granules for encapsulation. The ethanolic extract was also used in formulating an oral suspension. Pharmacopeia tests such as uniformity of weight, disintegration, drug content, and dissolution were carried out on the formulated capsules. The formulated suspension was also assessed using the following parameters; viscosity, flow rate, drug content, dissolution, sedimentation rate, and sedimentation volume. The dried ethanolic extract and formulated granules exhibited good flow properties. The formulated capsules exhibited optimal in vitro release of extract (>90% after 45 minutes) and passed the uniformity of weight, disintegration, and drug content tests. The formulated suspension also passed the drug content test and had a good sedimentation rate, sedimentation volume, and flow rate. The formulated suspension also exhibited pseudoplastic flow, optimal viscosity, and a good in vitro release profile (>90% after 45 minutes). Capsules and suspension of the ethanolic extract of Cola nitida seeds have been successfully formulated and can be used as standard dosage forms for the management of diarrhea.