4A.2.9.2. Differential Scanning Calorimetry (DSC): DSC analysis measures the heat loss or heat gain resulting from physical or chemical changes within a sample as a function of temperature. DSC analysis was carried out to study the polymorphic transitions exhibited bythe SLN formulation. It was carried out for pure drug, bulk lipids L2 and L3 and the two lyophilized formulations. Thermal behavior of the developed formulation was studied using a differential scanning calorimeter (Universal TA Model Q 200). About 5mg of sample was placed in 50µL Fig 4A.9 DSC thermogram of Pure Drug perforated aluminium pans and sealed. The sample was purged with pure dry nitrogen at a flow rate of 50 ml/min. DSC scan was carried from 0-300 0C at a heating rate …show more content…
no. 4A.13: DSC thermogram of Lipid 3 Fig 4A.14: DSC thermogram of Batch B Fig 4A.15: Integrated DSC Curves of Drug, Lipid 3and Formulation B 4A.2.9.3. X-ray Diffraction (XRD): XRD analysis was carried out to study the degree ofcrystallinity of the drug, lipids and the formulations. Studies were carried out using Philips Expertpro MPD diffractometer (PAN Analytical Inc Germany) with resolution of 0.001Aº. Vacuum grease was applied over the glass slide to stick the sample. About 10 mg of sample was sprinkled over to make a layer having a thickness of ~0.5 mm. The samples were radiated using a Cu target tube and exposed to all lines (λ-1.54056). Scanning angles ranged from 5º to 40º of 2θ. The current used was 30mA and voltage of 40kV. XRD analysis was carried out for the pure drug, physical mixture of drug with each of the lipids (L2 and L3) and the two lyophilized batches (AL and BL). Drug peak has disappeared in XRD of Nanoparticle 3 which probably may be due to conversion of Tamoxifen citrate from crystalline state to amorphous state or dissolution during the heating involved in the preparation of solid lipid nanoparticle or may be another phenomenon is drug may be present in polymeric amorphous phase. (Fig
Craig, D. Q. (2002). Pharmaceutical Applications of Micro-Thermal Analysis. Journal of Pharmaceutical Science, 91(5), 1201-1213.
The purified unknown had a melting point range, as seen in Table 1, of 135-137ºC. When the unknown was combined with acetanilide, the melting point range of the mixture was much lower, at only 97-106ºC. The literature melting point of acetanilide is 114ºC where the literature melting point of phenacetin is 135ºC. When the unknown was combined with phenacetin, as seen in Table 1, the melting point range of the mixture was very close to that of the purified unknown, 134-138ºC, and the literature value of phenacetin. It could therefore be concluded that, based on the solubility and melting point of the unknown component, the unknown could be identified as
...om aggregation and floating behavior of drug particles during dissolution. All proliposomal powders showed 67.5 to 91.2% drug release with following order KPL3>KPL5>KPL0>KPL4>Pure drug within 5 min which indicated improved dissolution of drug in the form of proliposomes. The improved dissolution of ketoprofen in proliposomal formulation may be due to the hydrophilic nature of pearlitol which facilitate the quick hydration of proliposomes to transform into liposomes, enhanced solubility of poorly water soluble drug by amphiphilic HSPC or altered physical state of drug entrapped in the bilayers from crystalline to amorphous state and it may be also due to increased effective surface area and wetting characteristic of unentrapped drug upon contact with dissolution medium as fine dispersion which was adsorbed over the porous water soluble carrier i.e. pearlitol SD 200.
In this case study, our concern goes for the chitosan nanoparticles; firstly nanoparticles are able to adsorb and/or encapsulate a drug, thus protecting it against chemical and enzymatic degradation. Furthermore the encapsulated drug may be prevented from crystallization, thus forming a solid solution. Depending on drug solubility in the carrier, a drug load varying from only a few percent up to 50%] Secondly, chitosan is ...
Solubility is based on the highest-dose strength of an immediate release product. A drug is considered highly soluble when the highest dose strength is soluble in 250 mL or less of aqueous media over the pH range of 1 to 7.5. The volume estimate of 250 mL is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water. A drug substance is considered highly permeable when the extent of intestinal absorption is determined to be 90% or higher. Otherwise, the drug substance is considered to be poorly permeable. (Yu et al., 2002)
Discuss the possible drug and excipient-related constrains of the formulation (no identity of the drug was given to you at this
About 1 gm. coarse powder was weighted and transferred to a 500 ml conical flask containing 100 ml of water. It was maintained at moderate boiling for 30 minute on water bath. It was cool and filtered in to a 100 ml volumetric flask. Volume was diluted by adding sufficient amount of water. The decoction was poured in test tube, and then shaken in a lengthwise motion for 15 seconds. They were allowed stand for 15 minutes and the height of foam was measured to determine the foaming index.
After the water, has been boiling for 10 minutes, and the temperature inside the test tube has been stable for 5 minutes, record the temperature and remove the thermometer.
As we discussed above that pharmacokinetic and pharmacodynamics can be seen as two sides of the same coin in order to gain better understanding of their efficacy and safety profiles.” Generally it is possible to make fairly robust predictions of the pharmacokinetic profile in man using in vitro systems and preclinical pharmacokinetic studies. A previously published survey on the causes of failure in drug development indicated that inappropriate pharmacokinetics were a major cause such as; factors as low bioavailability due to high extraction or poor absorption characteristics, short elimination half-life leading to short duration of action and excessive variability due to genetic or environmental factors. This observation has led to an increased emphasis on pharmacokinetic input to the drug discovery process throughout the pharmaceutical industry. However, it is important to realise that this may only permit the rejection of compounds to b...
Weight of the crystallized acetaminophen (MW = 151.2) the percentage yield was calculated. This calculation was based on the original amount of p-aminophenol used at the beginning of this experiment. Melting point of products was determined and comparison of the final product with that of the crude acetaminophen was carried out. Also compared was the colors of the crude, decolorized, and pure acetaminophen. Pure acetaminophen melts at 169.5 -171°C.
== § Test tubes X 11 § 0.10 molar dm -3 Copper (II) Sulphate solution § distilled water § egg albumen from 3 eggs. § Syringe X 12 § colorimeter § tripod § 100ml beaker § Bunsen burner § test tube holder § safety glasses § gloves § test tube pen § test tube method = == = =
Firstly, a burette was taken and rinsed with distilled water. Then it was rinsed using the provided NaOH solution.
The report is written to explain DSC, the thermal analysis technique. In this technique the differential analysis on the base of reference material is done at different temperature. A very close and similar technique is DTA (Differential Thermal Analysis) . In these technique the material is heated at different temperature although sometimes isothermal analysis also done for specific applications. The temperature is recorded for any heat release or absorption. So the heat capacity is measured at those temperatures. Two possible modes for DSC are power compensation mode and heat flux mode DSC. So, DSC is a technique which measure the heat capacity at various temperature of material and reference.
Materials and Methods: An ion exchange chromatography column was obtained and set up for purification with the addition of 0.5 ml ion exchange matrix. 1 ml
In light of the findings of the study, the pharmacokinetic parameters of this drug would v...