The ICH stands for "international council on harmonization of technical requirements for registration of pharmaceutical for human use" it's an initiative which brings together regulatory bodies and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. ICH guidelines include 'Q' series quality guidelines for harmonization. The amendment in analytical procedure development and the changes in validation of analytical procedure ICH Q2 (R1) is proposed to develop a new quality guideline and providing principles relating to analytical development procedures. Applying this guideline will improve regulatory communication between industry and regulators and Q2(R1) will include validation principles that cover analytical use of spectrometric data (e.g, NIR, NMR, Raman OR MS).

No abstract

Aim of the current research work to conduct bio availability of Nicardipine Hydrochloride S-SMEDDS in rats, compare with pure drug and Marketed Formulation. Study is conducted by using Wistar rats. 3-Groups were divided into Set-A Pure Drug, Set B: Marketed formulation, Set C: Optimized formulation, Total 18 healthy rats were selected, 6 in each group with weight of 300±50g Rats were labeled by numbers. Blood samples were collected from Tail vein method at pre-determined time intervals then blood samples were analyzed by validated HPLC method. S-SMEDDS exhibit cmax at 1429.58±107.40ng/mL, tmax at 0.75Hr, AUC(0-t) at 3042.05±333.35 ng. min/ml and t1/2 at 3.49±0.016 hr. AUC and maximum plasma concentration of the S-SMEDDS is higher than pure Nicardipine Hydrochloride drug and marketed formulation it indicates S-SMEDDS produce more bioavailability than Nicardipine Hydrochloride powder.

The study purpose is to further enhanced the rate of dissolution for poorly water soluble drug Nicardipine Hydrochloride (Antihypertensive Drug) which is poorly soluble in nature by using very famous technique called Smedds and liquisolid compact method, The prepared Liquid -SMEDDS were converted into S-SMEDDS by using Neusilin US2 as a Carrier, Aerosil 200 as a Coating agent, Crosscarmellose sodium as a Super disintegrant, Microcrystalline cellulose as a Diluent, Magnesium stearate as a Lubricant, We evaluated our preparation by their micrometric properties, DSC, XRD, SEM, TEM, In vitro dissolution of formulation was studies and compare with marketed formulation, in result liquisolid tablets shows higher % of dissolution, We also evaluated its stability studies at 400C±20C temperature and 75±5% RH for three month (accelerated stability study) which showed no major change in percentage drug content and its release patent.