An article on evaluation of dosage forms. Viscosity measurement: Viscosity is a property of liquids that is directly Higher the .. to be absorbed from a solid dosage form after oral administration, it must first be in solution, and. To conform the requirements of pharmaceutical oral liquids during manufacturing , in-process quality control (IPQC) tests are done as per. at developing oral administrable soft gels (liquid fill). pharmaceutical .. Table No Evaluation parameters of EVG liquid fill formulations.
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Liquid Dosage Forms
Off is an open access article distributed under the Creative Commons Attribution Licensewhich permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The present investigation includes the preparation of liquid filling formulations for soft gels using an antihypertensive drug, valsartan VALin order to improve its dissolution properties and thereby its bioavailability. Formulations were prepared using excipients like polyethylene glycol PEGpropylene glycol PGpolyvinylpyrrolidone PVP Kantioxidants, ethanol, and purified water.
Prepared formulations were evaluated for appearance, pH, drug content percentage, viscosity, stability, and in vitro dissolution studies. The compatibility between the drug and excipients in formulations was confirmed by FTIR spectra. The drug contents were in the range of From the studies, it ogals be concluded that VAL liquid filling formulations for soft gels were successfully prepared with in vitro dissolution properties superior when compared to VAL itself.
They show extremely low aqueous solubility throughout the physiological pH range, resulting in low rvaluation inconsistent bioavailability when administered as solid oral dosage forms. Liquids, in contrast, generally have better bioavailability and one such liquid dosage form is soft gel [ 2 ]. The soft gel dosage form offers several advantages over other oral solid dosage forms, such as delivering a liquid matrix designed to solubilize and improve the oral bioavailability of a poorly soluble compound as a unit dose solid dosage form, delivering low and ultralow doses of a compound [ 3 ].
VAL solubility is low in aqueous fluids, especially in gastric fluids its absorption is dissolution rate limited [ 45 ]. The drug is rapidly absorbed after oral administration and median values of 2.
From the literature review, it is clearly evident liquic most of the works oralls published with cyclodextrin inclusion complexation [ 7 ], solid dispersions [ 89 ], self-microemulsifying drug delivery system [ 10 ], and other solubilization technologies for improving the solubility, dissolution, bioavailability, and pharmacokinetic properties of VAL. However, Mbah CJ studied evvaluation solubility of VAL in solvents like oralw alcohol and propylene glycol and also in some surfactants [ 1112 ].
No clear reports evaljation published on the liquid filling krals for soft gel dosage forms in order to improve the in vitro dissolution properties and thereby oral bioavailability of VAL. Hence, the present investigation was aimed at developing oral administrable soft gel liquid filling pharmaceutical formulations of VAL with improved dissolution properties.
All the chemicals and reagents used in the study were of analytical grade.
Drug fill solution was prepared by accurately weighing required quantities of VAL along with various excipients as shown in Table 1. The solution was mixed until it becomes clear and finally the volume was adjusted with PEG The prepared formulations were sonicated for 3 minutes in order to remove any entrapped air.
The formulations of all samples were simply placed onto the ATR crystal and each sample spectrum was collected. Clarity and color change are the most important characteristic features of liquid filling formulations. All developed formulations were evaluated for clarity by visual observation against if black background.
Soft gel formulation should have a pH range between 2. Uniform distribution of active ingredient is very important to achieve dose uniformity. The viscosity measurements were made in triplicate using fresh samples each time.
Liquid Dosage Forms
Liquid formulations were filled into hard capsule size 1 and dissolution studies were performed. As the capsule tends to float in the dissolution medium, sinkers were used. Dissolution experiments were conducted in triplicate [ 14 ]. Stability testing is performed to ensure that drug products retain their fitness for use until the end of their expiration date.
Liquid filling formulations were prepared using PEGPG as water miscible solvents either alone or in combination, and water or ethanol as vehicle, with prals without PVP K 30 and antioxidants. Prepared formulations were evaluated for further studies. From the overlaid FT-IR or as shown in Figure 1it was confirmed that VAL in liquid state was compatible with different excipients used in the formulation. The formulations F1—F11 or homogeneous and colorless and no precipitation of drug was observed.
From Table 2all the formulations were transparent in appearance. The pH of the formulations was about 6. From Table 2the pH of all liquid filling formulations was suitable for further studies. The drug content was evsluation the acceptable range for all formulations indicating uniform distribution of drug, that is, solubilization of VAL in all the formulations.
From Table 2 evaluaiton, VAL content was found to be Viscosity is one of the oals parameters which provide vital information during the optimization of the liquid filling formulation for soft gels.
In general, the viscosity of liquid filling formulations for soft gels is in the range of 0. The consistency and viscosity of the filling formulations were related to each other because both were dependent on the concentration of PVP K Evaluatoon was clearly evident that the dvaluation and consistency of liquid filling formulations were affected by concentrations of PVP K 30 and PEG The dissolution profiles showed that VAL dissolution was influenced by the solvents containing PVP K 30 rather than antioxidants incorporated in the formulation of the fill liquid.
This showed that PG in a lower concentration was suitable for dissolution. In F5, water was replaced with ethanol to evaluate the effect on VAL dissolution.
The comparative dissolution profile was shown in Figure 5. Hence, the selection of appropriate rpm was important in eavluation development of soft gel formulations. Overall, all the liquid filling formulations gave higher release rate constant values when compared to pure VAL. The formulations showed no changes in clarity, colour, and precipitation at the end of 3 months. However, after 3 months, formulations F7, F8, and F9 containing PVP K 30 and antioxidants, a color change pale yellow color was observed, but no precipitation of drug.
Preparation and Evaluation of Valsartan Liquid Filling Formulations for Soft Gels
The percent VAL contents were also within the limits and the stability data was given in Table 3 and shown in Figures orxls and 8. All the liquid filling formulations showed good physicochemical properties.
The formulations were stable up to 6 months without undergoing any degradation. However, after 3 months, the color change pale yellow was observed with formulations F7, F8, and F9. The authors are thankful to Aurobindo Pharma Ltd.
Indexed in Web of Science. Subscribe to Table of Contents Alerts. Table of Contents Alerts. Abstract The present investigation includes the preparation of liquid filling formulations for soft gels using an antihypertensive drug, valsartan VALin order to improve its dissolution properties and thereby its bioavailability.
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Material and Methods 2. Preparation of Liquid Filling Formulations Drug fill solution was prepared by accurately weighing required quantities of VAL along with various excipients as shown in Table 1. Evaluation parameters for VAL liquid filling formulations. Comparative in vitro dissolution profile for liquid filling formulations F4, F6, F8, and F Comparative in vitro dissolution profile for liquid filling formulations F5, F7, F9, and F Comparative in vitro dissolution profile for F4, F8, and F9.
View at Google Scholar C. De Matos Jensen, R.