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ABSTRACT

A simple and reliable reverse phase high-performance liquid chromatography method was developed and validated for analysis of Atorvastatin and Telmisartan in pure and pharmaceutical dosage form. The method was developed on symmetric C18 (4.6 x 150mm, 3.5 mm, Make: Hypercil), with a mobile phase of phosphate buffer (P_H 3.0): Acetonitrile (40:60) %v/v. The effluent was monitored by Waters HPLC model containing Alliance 2695 with 2487 detector, variable wavelength prominence UV/ VIS detector SPD-20A (VP series). Calibration curve was linear over the concentration range of 50–90μg/ml for Atorvastatin and 12.5–22.5 μg/ml for Telmisartan. Recovery of Atorvastatin and Telmisartan was found to be in the range of 100.2 -99.80%.  The limit of detection (LOD) and quantification (LOQ) were 2.97 and 9.79 for Atorvastatin and 2.93 and 9.95 for Telmisartan, respectively. The retention time and run time was very short; hence it is cost effective, making it more economical and rapid. Hence, this method can be used for the analysis of large number of samples.

Key Words:- Atorvastatin, Telmisartan, RP-HPLC, Validation.

ABSTRACT

Controlled release formulation offers a number of advantages in therapeutics. Metformin Hcl is an anti diabetic drug used in treatment of Type-2 Diabetics Mellitus was used as a model drug to develop a Controlled release formulation. The objective of the present work was to formulate Controlled release tablet formulation containing Metformin Hcl in order to provide a prolonged effect and relatively constant effective levels of these drugs in the treatment of Type-2 Diabetics Mellitus. In this present study Controlled release tablet of Metformin Hcl was prepared by using wet granulation method and using different Hydrophilic polymer. The Fourier Transform Infrared Spectroscopy study reveals that there is no interaction between the polymer and drug. The prepared tablets evaluated in terms of their pre-compression parameters, post-compression parameters, in vitro release and Kinetic release study. The results conclude that FMST-6 (91.433%) can be considered as a optimized formula for Controlled release of drug, when it is compared with Marketed product (Metformin Hcl 500mg CR tablets (GLYCIPHAGE SR) (89.433%)) for 8hours. Kinetic treatment to the in vitro release data revealed that the drug release followed zero order non - fickian diffusion, It means the release of drug from tablet dissolution and diffusion both mechanisms are used.

Key Words:- Metformin Hydrochloride, HPMC K4M, Carbopol 934-P and Xanthan gum, Wet granulation method, In vitro and Kinetic release study.

ABSTRACT

Simple precise accurate UV Spectroscopic method has been developed and validated for estimation of valsartan in bulk and tablet dosage form. UV Spectroscopic method which is based on measurement of absorption of UV light, the spectra of valsartan in methanol and water (1:1) showed maximum wave length at 250nm and calibration graphs were plotted over the concentrations ranging from 2-10µg/ml of valsartan with correlation coefficient 0.9999 validation was performed as per ICH guidelines for linearity, accuracy, precision and percentage recovery. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 1.95 and 5.91 respectively by simple UV Spectroscopy .The proposed method was validated.

Key Words:- valsartan, methanol, distilled water, UV spectroscopic method, validation.

ABSTRACT

The purpose of this work was to develop solid oral formulations of Telmisartan tablets using high shear granulation process with a relatively rapid drug release similar to that of the reference product Micardis. The Formulation development work was initiated with wet granulation as the API is very static in nature and having very poor flow property. In order to improve solubility and drug release, Telmisartan is converted to its sodium salt by dissolving in aqueous solution of Sodium Hydroxide. Tablets were evaluated for various parameters such as Weight variation, Thickness, Hardness, Disintegrating Time; Friability and In-vitro dissolution studies were performed using United States Pharmacopeia (USP) apparatus type II. Telmisartan has poor and pH dependent water solubility in order to enhance its dissolution surfactant and different alkalizers were used in an appropriate ratio. Nine batches of conventional Telmisartan tablet were developed and among them F-8 showed satisfactory physical parameters and release of a drug within 60 minutes with maximum release of 99.9% which is comparable to reference product.

Key Words:- Telmisartan, wet granulation, In-vitro dissolution.

ABSTRACT

The investigation was concerned with design, preparation and evaluation of oral floating sustained release tablets of Lamivudine using different natural polymers such as Chitosan, Guar gum and Xanthan gum. The formulated different ratio of oral floating sustained release tablets of Lamivudine were evaluated by different parameters for improve the drug effectiveness. The FT-IR studies were confirmed no chemical interaction between the Drug and Natural polymers. The Lamivudine oral sustained release matrix tablets were prepared by using wet granulation method. The prepared granules were evaluated for angle of repose, bulk density, compressibility index and hausner‟s ratio. The tablets were subjected to thickness, weight variation test, hardness, friability, drug content, in vitro release, kinetic release and stability studies. The results conclude that FM-7 (95.10%) can be considered as a optimized formula for sustained release of drug, when it is compared with Marketed product (Lamivudine 300mg tablets (Epivir) (91.67%)) for 24 hours. Kinetic treatment to the in vitro release data revealed that the drug release followed first order, non - fickian diffusion, It means the release of drug from tablet diffusion mechanisms are used.

Key Words:- Floating tablets, Lamivudine, Natural polymers, In vitro kinetics and Stability studies.

ABSTRACT

The purpose of this work was to develop sustained release bilayer floating tablets of Quinapril HCl by direct compression method. The type and the concentration of the polymer are optimized to show the maximum retentive effect with good drug release profile. The tablets were prepared by polymers like HPMC k 100, carbopol, xanthangum, guargum. Sodium bicarbonate acts as gas generating agent with a view to deliver the drug at sustained manner in GIT & consequently in to systemic circulation. Formulations were prepared and evaluated for physical parameters & were found within prescribed limits. The in vitro drug release studies were performed using USP apparatus type IІ. The drug release was dependent on the type and concentration of the polymer. Drug release was faster from tablets prepared with Carbopol, Xanthan gum and HPMC alone. However, in combination tablets sustained drug release effectively. The rate and mechanism of release of tablets were analysed by fitting the dissolution data into kinetic models. The In-vitro drug release followed Zero order Kinetics and drug release was found to be diffusion controlled & it follows Higuchi diffusion Mechanism model. It can be concluded that the optimized batch F6 selected as best formulation, shown buoyancy lag time of 17 sec, total floating time of 12 hrs and drug release of 99.636% by adopting biphasic drug release pattern in a single dosage could improve patient compliance by increasing the gastric retention time and give better disease management.

Key Words:- Floating, Sustained release, Quinapril, Direct compression.

ABSTRACT

In present investigation was intended to formulation and screening of anti-rheumatic activity of herbal extract based transdermal pad using combined petroleum ether extract of Cardiospermum halicacabum L. and Delonix elata L. leaves (CPCD) on experimental models of arthritis, viz. turpentine oil (acute non-immunological arthritis) and formaldehyde (Chronic non-immunological arthritis) induced arthritis. The extracts obtained from successive extraction were subjected to preliminary phytochemical investigation and antiarthritic activity was evaluated by inducing turpentine oil and formaldehyde. Body weight and histopathological changes were observed. The results indicate that anti-rheumatic transdermal pad (50&100mg of CPCD) and CPCD 400mg/kg protects rats against turpentine oil and formaldehyde induced arthritis. The overall results indicated that oral & topical dosage of CPCD exerts a potent protective effect against turpentine oil and formaldehyde-induced arthritis in rats. These findings demonstrate that the present study validates the ethnomedicinal use of leaves of Cardiospermum halicacabum L. and Delonix elata L.in the treatment of arthritis conditions.

Key Words:- Anti-rheumatic transdermal pad, Cardiospermum halicacabum L. and Delonix elata L., turpentine oil and formaldehyde induced arthritis.

ABSTRACT

                Ritonavir, a widely prescribed anti-retroviral drug, belongs to Class II under \'BCS\' and exhibit low and variable oral bioavailability due to its poor aqueous solubility. Ritonavir is practically insoluble in water and aqueous fluids. Its aqueous solubility was reported to be 2.56 mg/100 ml. As such oral absorption of ritonavir is dissolution rate limited and it requires enhancement in solubility and dissolution rate for increasing its oral bioavailability. The objective of the present study is to enhance the dissolution rate of ritonavir by solid dispersion in water soluble and water dispersible carriers. The feasibility of formulating the solid dispersions in to compressed tablets with rapid dissolution was also investigated. A total of 21 solid dispersions of ritonavir were prepared and evaluated. The dissolution of ritonavir from all the solid dispersions prepared was rapid and several times higher than the dissolution of ritonavir as such. Among the three water soluble carriers PVP solid dispersions gave highest enhancement (9.93 fold) in the dissolution rate of ritonavir. The order of increasing dissolution rate observed with various water soluble carriers was PVP > HPC-L > HPMC. Water dispersible superdisintegrants gave much higher enhancement in the dissolution rate of ritonavir.  Among the superdisintegrants tested, croscarmellose sodium and crospovidone gave markedly higher enhancement in the dissolution rate of ritonavir, 47.24 and 28.15 fold respectively. The order of increasing dissolution rate observed with various superdisintegrants was croscarmellose sodium > crospovidone > primogel >Prosolve.  FTIR indicated no interaction between ritonavir and the two carriers, PVP and croscarmellose sodium, which gave highest enhancement in the dissolution rate of ritonavir. Ritonavir is present is an amorphous form in the solid dispersions which contributed to the rapid dissolution of ritonavir from the solid dispersions. The dissolution rate and dissolution efficiency of ritonavir were markedly enhanced by solid dispersion of ritonavir in water soluble polymers and superdisintegrants. Solid dispersions of ritonavir in PVP, crospovidone and croscarmellose sodium could be formulated into tablets by both wet granulation and direct compression methods. Ritonavir tablets formulated employing solid dispersions gave much higher dissolution rates and DE₃₀ values when compared to plain tablets.

Key Words:- Ritonavir, Solid Dispersions, Water soluble carriers, Water dispersible carrier’s tablets, Dissolution Rate.

ABSTRACT

Irrational use of medicines is a global problem and in developing countries this problem is enormous and not well documented. Few household surveys on medicine use were conducted in India and were rarely published or not fully documented. The aim of the present household survey was to evaluate the use and storage of medicines in the Chittoor district of Andhra Pradesh, India and identifying related problems. A cross-sectional study was conducted using a set of household interview questionnaire. The study included 500 households in Chittoor district of Andhra Pradesh, India. Results showed almost 3/4th households (74.67%) had medicines at homes and 28.57% of medicines found at household are not used at all. 32% of households are self-medicated. 90.66% of respondents check the expiry date of medicine before its use. 8% of house hold keeps the leftover medicines for future use. About 27.27% stored medicines in Cupboard and 16.67% in Drawer, 3% in cover and 1.52% stored in a refrigerator. About 6% of the stored medicines are bad condition. 1.56% of medicines at homes were already expired. 73% of medicines were with adequate labels. 88.63% respondents had correct knowledge of dosage of the medicines at homes. It is obvious that there is inappropriate use of medicines among the sampled population and hence there is a conclusive need for promoting rational use of medicines in the community to enable people to store and use medicines in a proper way.

Key Words:- Household, Storage, Irrational, Community, Self-medication, Rational Use, Medicines.