Filtered the solution through 0.45 µm nylon filter Buffer having pH 3.70 used as Mobile phase A and mixture of methanol, acetonitrile and tetrahydrofuran (50: 50: 2 v/v/v) were used as Mobile phase B. Diluent: Prepared a mixture of buffer and methanol (80: 20 v/v). Placebo preparation (Placebo I): Weighed accurately and transferred 255 mg of placebo to a 100 mL volumetric flask. Add 40 mL of methanol and sonicated for 10 mins and add about 30 mL of diluent and again sonicate for 15 mins. Allow to equilibrate at room temperature (RT) and dilute to volume with diluent. Filter the solution through 0.45 µm nylon filter (25 mm) by discarding first few mL of the filtrate.
Synthesis of 3-[5-(4-substituted) phenyl-1,3,4-oxadiazole-2yl]-2-styrylquinazoline-4(3H)-ones was carried out by following steps: Step 1: Synthesis of 4- substituted benzaldehyde semicarbazon51(2) Semicarbazide Hydrochloride (0.1M) and sodium acetate (0.2M) was added and dissolved in 15-20ml of distilled water placed in flat-bottomed flask. In a separate beaker containing required aromatic aldehyde (1) (0.1M) was dissolved in aldehyde free alcohol. This ethanolic aromatic aldehyde solution was added slowly to the solution of semicarbazide hydrochloride. The precipitate, which gets separated, was filtered, dried and recrystallised from 95% hot ethanol. Table 1: Quantity of aldehydes taken S. No.
The UV sensitive bands were purified using repetitive preparative TLC followed by crystallization. The identity of Ecdysterone was established by the following procedure: HPLC, with a Shimadzu LC-20, a Phenomenex C-18 reverse-phase Luna C18 which was used with a mobile phase of MeOH:Water (1:1) at 1.80 mL/min and the absorbance was monitored at 254 nm. Studies confirming the presence of a single peak of the isolated Ecdysterone, with a characteristic UV absorption at 246 nm were done using commercial standard Ecdysterone (Sigma) (Figure 2 A and B).
Tablets containing combination of sodium starch glycolate, croscarmellose & crospovidone showed 100% drug release within 10 minutes. It was observed that with the increase in concentration of superdisintegrants, the disintegration time decreased in following order: - Crospovidone > crosscarmellose > sodium starch glycolate.Faster dissolution was obtained when combination of superdisintegrants was used. Dissolution studies indicated, that tablets prepared by combination of three superdisintegrants showed rapid
Only few technologies can produce tablets that are sufficiently hard and durable to allow them to be packaged in multidose bottles, such as Wowtab® by Yamanouchi-Shaklee, and Durasolv® by CIMA labs. Hygroscopicity Several orally disintegrating dosage forms are hygroscopic and cannot maintain physical integrity under normal conditions of temperature and humidity. Hence, they need protection from humidity which requires specialized product packaging. Amount of drug The application of technologies used for ODTs is limited by the amount of drug that can be incorporated into each unit dose. For lyophilized dosage forms, the drug dose must be lower than 400 mg for insoluble drugs and less than 60 mg for soluble drugs.
For this purpose 0.1N HCl, pH 4.6 buffer, pH 6.8 buffer and purified water were used. Highest dose of the drug i.e., 400mg was dissolved in 250 mL of medium and was kept untouched for 6 hrs. Later on the insoluble drug was filtered off and the solution was analysed by HPLC technique to find out the solubility. Based on the solubility calculated the D/S ratios were calculated. The FDA guidance on “Dissolution Testing of Immediate Release Solid Oral Dosage Forms” says that a drug substance is considered highly soluble when the dose/solubility volume of solution are less than or equal to 250 mL.
The hydrophilic property will prevent the dissolved drug molecule to separate from the hydrous exterior into a lipophilic bio membrane and then permeate the membrane. High-throughput screening techniques involved in the drug development have resulted in an increased number of lipophilic water-insoluble drugs whose clinical advantages are affected by their insolubility in water. The effect
A clinical trial in a multicentre open longitudinal was carried with 479 patients suffering from migraine and 6mg sumatriptan was given by autoinjector, subcutaneously and conventional treatment for other group. sumatriptan autoinjector was found to be effective and well tolerated than the conventional treatment. The response percentage was 82 in the autinjector group and 30 in the conventional treatment (Schoenen et al
SOLID LIPID NANOPARTICLES (SLNs): SLN’S are recent advances to vesicular drug delivery systems. It consist of solid lipid core surrounded by a phospholipid layer. The lipid used should be biocompatible and exist in solid state at room temperature and body temperature. Slns are not easily phagocytised by reticulo endothelial system and hence remain in the systemic circulation for longer time period. Slns can be linked to specific ligands which will recognise receptors present on specific cells and hence achieve targeted drug delivery thus enhancing bioavailability of the drug.
Stabilizers such as surfactants or phospholipids are necessary for controlling the desired particle size. This method is not very convenient for large scale production but still can be used for production of soft drugs. SkyePharma Canada Inc. uses this process for production of submicron particles of poorly soluble drugs