Simulated Salivary Fluid pH 6.8, Water . All films exhibited good content uniformity and nanoparticle redispersibility up to 50 wt% griseofulvin, while E4M films above 50 wt% griseofulvin had slightly worse content uniformity and poor nanoparticle redispersibility. undissolved or immiscible drug distributed throughout a. vehicle. ties, reconstitution time, endotoxins/pyrogens, particulatethe container, actuator, and … Vehicle: 8.4 % sodium bicarbonate injection solution USP. The paddles of USP Type II apparatus (TDL 06L, Electrolab, India)were stirred at 50rpm and 5 . Review. Identification Test-determines the physical and chemical reactions particular for the compound, gives the gross physicalappearance. Similar samples were subjected to centrifugation at 4000 rpm for 30 mins. USFDA-CGMP guidelines To assure batch uniformity and integrity of drug product,written procedures shall be established and followed. At regular interval one tube was removed and shaken vigorously to redistribute the sediment and the presence of deposit if any was recorded 23 5.4. Pharmaceutics, Pharmacy Notes. Experiments were performed according to dissolution test No. Water was added to the beaker to make a total If settling occurs, leading pharmacopoeias require that suspensions be redispersible by shaking, but a standardised testing procedure for this property is not available. Controlled/delayed release. Test per General Chapters:<71> Sterility Tests Organism Strain (Cell Line) Excelsior Code Bacillus subtilis 6633 GP-01E The QC Test Suspensions are ready-to-use microbial suspensions which require no rehydration or dilution prior to use. Tablet, Liquids, Parenteral, and Ointments etc. •Dispersions containing particles of smaller size are termed fine dispersions (0.5 to 10 μm) colloidal range, Magmas and gels are fine dispersions . Improved dry/wet redispersibility and dissolution. AUCs for both reference and test. Field of the Invention . Drugs in suspension are prepared mainly for: Oral (e.g. . The results show that cooling the FNB-PF68 emulsion in the presence of sonication produced suspensions with acceptable 7-day physical stability, whereas cooling the same without sonication led to severe particle aggregation within 20 min. Apparatus IV showed the desired discriminatory power and was selected and optimised as QC test. Insulin Zinc suspension USP'95, IP'96 aq. Dissolution rate study of prepared suspension and marketed product at salivary pH Drug release was determined by adding suspension and marketed product (L-CIN suspension, Lupin Ltd.) equivalent to 125 mg of drug in 900 ml of dissolution medium in a USP type Lab India DS-8000 Apparatus using a The . 20 mg/mL suspension was stable for 56 days at 3-5 ºC and 23-25 ºC. Packaging Test-determines the material type, assembly, special properties and integrity. The redispersibility of suspensions was evaluated according to a method described elsewhere . Other Tests •alcohol content •redispersibility •particle size distribution •rheological properties About 5 ml suspension containing 200 mg of drug was placed on tongue and taste evaluated after 15 seconds. Drug release study of HP βCD complexed Albendazole suspension was carried out in USP XXIII dissolution test apparatus-II(Veego digital tablet dissolution test apparatus, model VDA-8D) and the dissolution medium was 0.1NHCL (pH 1.2).The volume of dissolution medium was 900ml, and it was maintained at 37±0.5 ℃ and stirred at An injectable composition of triamcinolone acetonide or anecoltab acetate is disclosed. [0121] The redispersibility results first show that redispersibility in water does not predict redispersibility in an electrolyte solution. suspension with 1.5%w/v colloidal silicon dioxide was found to be in the range of 5 to 60 µm indicating small particle size distribution. 20 ml of each suspension formulation was poured into 25 ml measuring cylinder and allowed to settle for a week. The test was carried out in triplicate, that is at 7 days intervals (Okoye et al., 2014). Based on the time and the effort required to convert the sediment to homoge-nous suspension, the formulations were evaluated. Isolation and Evaluation of Tamarind. 1 showed that there was a linear relation (r2 = 0.9809) Table 2: Physical parameters of ophthalmic suspension S. No. The rheological properties of both samples were examined using a rotational rheometer (MCR 302) at room temperature of 25 °C with current and shear rates ranging . The paddles of USP Type II apparatus (TDL 06 L, Electrolab, India)were stirred at 50 rpm and 5 mL aliquots were withdrawn at 5, 10, 15, 30 min intervals and the equal amount of fresh medium was replaced. A slide of above suspension was prepared, placed under microscope and measured the size of the particles. At regular interval one tube was removed and shaken vigorously to redistribute the The number of inversions required to resuspend the sediment of the suspension is the redispersibility value . The formulated suspension (50 mL) was transferred into capped cone tubes and evaluated for redispersibility at weekly intervals for 4 weeks, by turning it through a 180-degree cycle. 20 ml of each suspension formulation was poured into 25 ml measuring cylinder and allowed to settle for a week. Latin term Abbreviation Meaning ad ad to, up to ad lib. Distek 2100C USP II Apparatus. using USP II Type dissolution test apparatus at 50 rpm with temperature of 37 ± 0.5 ºC and 900ml 0.1 N HCL used as the dissolution medium. The quality of pharmaceutical dosage forms is essential to minimize or eliminate the risk of marketing unsafe products. Redispersibility; Suspensibility; Storage condition; For liquid products to be used as injections, eye drops or vaccines sterility, apyrogenicity test and particulate matter testing are necessary as additional tests. Thus, for unit dose solution products, they should deliver the label claim within the limits described in the USP. The suspension prepared by sodium CMC and hibiscus mucilage showed better redispersibility than hydroxy propyl methyl cellulose and tragacanth. 4. Abstract The content of active ingredient of single doses of a suspension depends to a large extent upon the redispersibility of the product. Mathematical and technical aspects of a procedure to test this property have been discussed in a preceding article. But some of the literature (7 from 28) have no data for physical stability ( Table 1 ). Redispersibility: The redispersibility of a suspension was evaluated qualitatively. h. every other hour ana a.a. or aa of each ante a. before ante cibum a.c. before food, before meals ante …. Ph. Redispersibility of suspensions sediment The redispersibility of suspensions was evaluated according to a method described elsewhere (Saeedi et al., 2003). Thus, for unit dose solution products, they should deliver the label claim within the limits described in the USP. Review the firm's data to assure uniformity of fill and test procedures to assure that unit dose samples are being tested. . Redispersibility was recorded as the number of inversions (strokes) required to completely resuspend the formulation in the cone tube [ 16 - 18 ]. In vitro dissolution testing (dissolution) plays a critical role in the life cycle of a generic drug product. Dose uniformity and redispersibility of pharmaceutical suspensions 2: assessment of three commercial erythromycin ethyl succinate oral liquids The content of active ingredient of single doses of a suspension depends to a large extent upon the redispersibility of the product. Detailed studies on redispersibility / resuspendability, syringeability, and sedimentation volume of the proposed finished product were performed in accordance with the WHO . Current USP Monograph for Dexamethasone, USP <197U> Absorptivity at 239 nm, calculated on the dried basis, does not differ by more than 3.0% Assay: HPLC Current USP Monograph for Dexamethasone TP-307-501 97.0% - 102.0% on a dried basis Any individual impurity NMT 1.0% Total Impurities NMT 2.0% Chromatographic Purity: HPLC Current USP Monograph . The proposed revision incorporates con-cepts outlined in a Stimuli to the Revision Process article, Devel-opment of a Compendial Taxonomy and . The taste of suspension was checked by panel method 11.The study protocol was explained and written consent was obtained from volunteers. In vitro test of dissolution Prepared suspension formulations were subjected for dissolution using a USP (XXII) rotating paddle dissolution apparatus (apparatus II). Steps involved in IPQC (1) Identify types of formulations manufacturing or going to manufacture, e.g. Test Limits Results 1 Physical Appearance Dense, white microfine suspension Passes 2 pH 5.0 - 6.0 5.62 3 Osmolality 255- 315 mOsm/Kg 307 mOsm/Kg 4 Particle Size 1 - 3 micron . The redispersibility time of dry suspension was 120 seconds which indicates easy . Thus, this study is aimed at evaluating the efficacy of <i>Grewia ferruginea</i> mucilage (GFM) as a suspending agent in metronidazole benzoate suspension. USP <1111> * Periodic-Skip . The effect of electrolyte on sedimentation volume (%) had dual effect. Pharmaceutics, Pharmacy Notes. The end point was taken when the base . [0122] Second, the redispersibility results show only one sample, Sample E, showed good redispersibility in electrolyte media, with a redispersibility of 99.1% in 0.01 M HCl and 99% in 0 . However, PEG 3350 and PEG 4000 are most preferably used. Procedure— Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the areas for the major peaks: the peak area of 4-aminophenol obtained from the Test solution is not greater than the corresponding peak area obtained from the Standard solution.USP29 The results shows that the CI/γ-Fe 2 O 3 suspension gives better redispersibility as the nanoparticles slow the rate of particles settling and prevent the formation of hard sediment. For selection of a dissolution method Test 1 (USP Apparatus IV, flow through cell) and Test 2 (paddle) of the USFDA OGD recommended dissolution methods were investigated in light of the extended release properties of the depot injection. The measuring cylinders were then manually and genteelly rotated at 180o. General Tests: 1. •The particles of the dispersed phase vary widely in size, •Dispersions containing coarse particles, usually 10 to 50 μm, are referred to as coarse dispersions; they include the suspensions and emulsions. the vehicle is dispersing phase or dispersion medium. Determination of the redispersibility The redispersibility of a suspension was evalu-ated qualitatively. The redispersibility test showed easy redispersion after only 4 revolutions without any sign of caking. The high sedimentation volumes (%) of suspensions, in turn, were accompanied by ease of redispersibility of that order. PLAY. iii. Terms in this set (43) Disperse Systems. The present invention provides improved triamcinolone acetonide suspension compositions and anecortab acetate acetate suspension compositions that are particularly suitable for ocular . Each suspension contains a consistent number of microorganisms standardised to deliver For selection of a dissolution method Test 1 (USP Apparatus IV, flow through cell) and Test 2 (paddle) of the USFDA OGD recommended dissolution methods were investigated in light of the extended release properties of the depot injection. USP <61>, Japan Ph. 2d. In vitro Dissolution Studies A USP dissolution apparatus II (Hanson Research, Northridge, USA) was used to characterize the dissolution of ACT suspensions. Less is the time taken to redisperse the sediment, the better is the redispersibility. To assess the redispersibility, the number of inversion cycles required to completely redisperse the suspension at the end of 24 h was measured (Table 3). In this review, almost all (98.9%) of the extemporaneous pediatric formulations are physically stable at all storage conditions. The ultimate test of redispersibility is the uniformity of suspended drug dosage delivered from a product, from the first to the last volumetric dose out of the bottle, under one or more standard shaking conditions [37]. In fact, the N value of the suspension was found to be higher than 1, resulting in pseudoplastic flow. Appropriate for suspension and time required to achieve resuspension should be specified . Ease of redispersibility as such, after freeze-thaw cycling and after centrifugation: The suspension was found to be easily redispersible as such and also after The USP does not provide for dose uniformity testing for oral solutions. This general information chapter is being revised in its en-tirety to represent current compendial thinking with respect to official preparations. (USP 2007). INTRODUCTION 1.1 Objective of the Guideline This guideline is intended to assist to the extent possible, in the establishment of a single set Suspension for Injection (Incepta Pharmaceuticals Limited), RH084 WHOPAR Part 6 May 2020 . Test Limits Results 1 Physical Appearance Dense, white microfine suspension Passes 2 pH 5.0 - 6 . The redispersibility of the suspension was checked by moving the Suspension samples for particle size after milling were prepared by removing a 1.2 ml sample from the holding tank of . pH 7.2 buffers (for remaining 6 . Ease of redispersibility as such, after freeze-thaw cycling and after centrifugation 2: Twenty milliliters suspension samples were subjected to 3 cycles of 4°C & 30°C each of 24 hours and assessed for their physical instability like phase separation and caking. h1151i Pharmaceutical Dosage Forms,USP 32 page 663. Suspensions are. Powder characterization (FT4, AOR) . Study of physical stability and redispersibility of suspension: The formulated suspensions were evaluated for physical stability by determining the sedimentation volume8. The effect of electrolyte on sedimentation volume (%) had dual effect.