SPHERICAL CRYSTALLISATION: A REVOLUTION IN THE FIELD OF PARTICLE ENGINEERING

Now-a-days direct tabletting technique is gaining more importance in Pharmaceutical manufacturing because it save money and time for tabletting but Good flowability and compressibility is prerequisite for drug to be prepared by direct compression. There are several techniques available to impart desired compressibility to drug, but the Spherical crystallization technique is the most promising one in which the drug crystals are modified using different solvents to directly compressible spherical agglomerates. Spherical agglomeration is particle engineering technique which involves the transformation of fine crystals into spherical shape which in turn enhances the powder properties such as particle size, shape, flow properties, solubility and bioavailability of pharmaceutical drug substances. The spherical crystallization further developed use with hydrophilic polymers to enhance dissolution rate characteristics of poorly water soluble drugs and can also be applied to sustain the drug release from solid dosage forms. The present review aims at the detailed comprehensive study about the technique, advantages and disadvantages, mechanism, different manufacturing methods of spherical agglomerates and characterization of spherical agglomerates

FORMULATION DEVELOPMENT AND EVALUATION OF DILTIAZEM HYDROCHLORIDE GASTRO RETENTIVE FLOATING TABLETS

The investigation was concerned with design and characterization of oral sustained release gastro retentive floating tablets of DiltiazemHCl in order to improve efficacy and better patient compliance. Present investigation was to formulate, evaluate and optimize gastro retentive tablet of DiltiazemHCl. This tablets released drug till 24 hrs due to floating mechanism of polymers. Gastro retentive floating tablets were prepared by direct compression method using various proportions of polymersHPMC K4M, HPMC K100M,Carbopol 934, Ethyl cellulose, Xanthan gum along with Sodium bicarbonatethe sustained release behaviour of the fabricated tablets was investigated. Tablets were prepared by directcompretiontechnique.Formulation was optimized on the basis of acceptable tablet properties and in vitro drug release. The resulting formulation produced robust tablets with optimum hardness, consistent weight uniformity and low friability. All tablets but one exhibited gradual and near-complete sustained release for DiltiazemHCl (90-100%) at the end of 24 h. The results of dissolution studies indicated that formulation Dtz15 was found to be most successful as it exhibits drug release pattern very close to theoretical release profile. A decrease in release kinetics of the drug was observed on increasing polymer ratio. KEY WORDS: Sustained release, Gastro retentive floating, Diltiazim HCL, HPMC K100M, Carbopol 934

SUSTAINED RELEASE MATRIX TYPE DRUG DELIERY SYSTEM: A REVIEW

Oral sustained release (SR) products provide an advantage over conventional dosage forms by optimizing bio-pharmaceutics, pharmacokinetics and Pharmacodynamic properties of drugs in such a way that it reduce dosing frequency to an extent that once daily dose is sufficient for penetration, polymer swelling, drug dissolution, drug diffusion and matrix erosion. Highly water soluble drugs like Diltiazem; Ranitidine has been formulated as sustained release matrix tablets. This article contains the basic information regarding design sustained release formulation and also the different types of the same. Developing oral sustained release matrix tablet with constant release rate has always been a challenge to the pharmaceutical technologist. Most of drugs, if not formulated properly, may readily release the drug at a faster rate, and are likely to produce toxic concentration of the drug on oral administration. Hydrophilic polymers have become product of choice as an important ingredient for formulating sustained release formulations.Key Words: Matrix system, Controlled drug delivery, Polymers.Â

AN UPDATED REVIEW ON DESIGN OF EXPERIMENT (DOE) IN PHARMACEUTICALS

DoE is a structured, organized method for determining the relationships among factors affecting a process and its output.It has been suggested that DoE can offer returns that are four to eight times greater than the cost of running the experiments in a fraction of the time that it would take to run one-factor-at-a-time experiments.It is always important before beginning experimentation to determine the objective of an experiment, and this is no different with DoE. Identifying objectives helps focus a team on its specific aims (scientific understanding of the task/problem in hand) over a period of time. It also helps indicate what resources are and assists in managing expectations from a study’s outcome. DoE studies in support of QbD are often a delicate balance between delivering defined, high-quality products and meeting predetermined time, labor, and financial constraints. Keywords: Quality by design (QbD), Design of experiment (DoE), Process analytical technologies (PAT), One factor at a time (OFAT), Quality risk management (QRM), Critical process parameters (CPP), Analysis of variance (ANOVA

AN UPDATED REVIEW ON MODIFIED RELEASE TABLETS

For some time now modified drug release has been studied and used extensively during the development of pharmaceutical drug products because of its advantages over immediate release formulations. As per the forecasting by Global Business Intelligence (GBI) research, the growth in oral drug delivery market will uplift in the coming years. Modified release drug products allow at least a two-fold reduction in dosing when compared to a drug that is presented in a conventional immediate release form. Modified release drug products are designed to release active pharmaceutical ingredient over a longer duration of time; At least, longer than an immediate release (I.R) formulation. Many Pharmaceutical companies also utilize the proprietary advantages of Modified release formulations to extend the patent life cycle of commercial products thereby bringing in new business. Keywords: Immediate release (I.R), Modified release (M.R), Novel drug delivery systems (NDDS), Loading doze (LD), Maintenance doze (MD), New Drug Application (NDA

A review on analytical method validation and its regulatory perspectives

Analytical methods plays vital role in the process of identification, separation and then quantification of chemical components in natural materials or synthetic materials based on their chemistry. The main purpose of the analytical method development and validation is to prove that proposed analytical method is accurate, specific, precise and robust in the pharmaceutical industry for analysis of a drug moiety. Analytical method development gives important information in the pharmaceutical industry, on the potency of a drug, the drug’s bioavailability, the drug’s stability and also its effects. The analytical method validation is essential for analytical method development and tested for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit and robustness. In summary, analytical method development and validation confirms that an accurate, precise and reliable potency measurement of a pharmaceutical preparation can be performed. Keywords: HPLC, HPTLC, UPLC, GC, MS, SO

A Review on Formulation and Evaluation of Gastroretentive Floating Tablet of Nifedipin

Different mass transport processes may occur during drug release from polymer-based matrix tablets, including water imbibition into the system, polymer swelling, drug dissolution, drug diffusion out of the tablet, and polymer dissolution. Depending on the type of drug, polymer and release medium and on the tablet composition, the respective processes are more or less important. Velasco et al.24 reported that the rate and mechanism of nifidipine release from HPMC K15M-based matrices were mainly controlled by the drug/ HPMC ratio, and that drug release was independent of the compression force in the range between 3 and 12 kN. The effects of the two formulation variables ‘‘HPMC/ lactose ratio’’ and ‘‘HPMC viscosity grade’’ on the release of adinazolam mesylate from cylindrical tablets was studied by Sung et al. The resulting drug release rate was found to increase with decreasing ‘‘HPMC/ lactose ratio’’ and decreasing ‘‘HPMC viscosity grade Keywords: HPMC, Floating tablet, Gastroretentive, Gastric residence

DEVELOPMENT AND IN VITRO EVALUATION OF FAST DISSOLVING TABLETS OF TIZANIDINE HYDROCHLORIDE BY DIRECT COMPRESSION METHOD

In the present work, fast dissolving tablets (FDTs) have been prepared by direct compression method using Tizanidine hydrochloride as a drug candidate. Tizanidine HCl is a centrally acting α-2 adrenergic agonist muscle relaxant with a slightly bitter taste having short half-life of 2.5 h. The tablets were prepared with three superdisintegrants e.g. sodium starch glycolate, crosscarmellose sodium and crospovidone. Formulations were evaluated for pre compression parameters such as bulk density, tapped density, angle of repose, Carr’s index and Hausner’s ratio. The prepared tablets were also evaluated for hardness, friability, thickness, drug content, disintegration time, wetting time and in-vitro dissolution studies. The compatibility of drug with other ingredients was checked by FTIR studies. In-vitro release is presented by zero order and first order plot. From the point of view of maximum drug release within 20 minutes, formulation TZN8 within 8 formulations is the best and hence optimized one. From this study it was concluded that fast dissolving tablets prepared by direct compression method using different superdisintegrants enhanced dissolution which will lead to improved bioavailability and effectiveness of tizanidine hydrochloride

Rawat S: A Review on Immediate Release Drug Delivery System

ABSTRACT Most common and popular route of administration of drug is oral route. Tablet form is the most widely used dosage form because of self-administration and ease in manufacturing. In most of the cases immediate on set of action is required as compare to conventional therapy. To achieve the rapid onset of action and eliminate the drawbacks of conventional therapy immediate release dosage form is now a days popular and used as a alternative oral dosage form. Immediate release tablet are very quickly after administration. Basic approach used in development is the use of superdisintegrants which provide rapid disintegration of tablet after administration

Development and Validation of a RP-HPLC Method for the Simultaneous estimation of Amoxicillin, Omeprazole and Tinidazole in fixed dose combinations

New liquid chromatographic technique was established for the simultaneous estimation of tinidazole, omeprazole and amoxicillin in the fixed dose combination (HP-KIT by Sun Pharma). RP-HPLC elution has performed by using the Phenomenex Luna column (250 mm x 4.6 mm) having internal diameter and the packing material of size 5µm) in isocratic mobile phase of solution A: acetonitrile at a ratio of 80:20 v/v (Solution A consists of Buffer: Acetonitrile: Methanol: Triethylamine in the ratios of 68:22:10:0.01 respectively). The selected flow rate was kept as 1 ml/min and selected wavelength was 230 nm was for detection of the drugs in UV detector. As per the ICH guidelines, the method validation was carried out. Moreover, the different parameters of method such as precision, specificity, linearity, robustness and accuracy were established. The time of retention for the tinidazole, amoxicillin, and omeprazole were 4.021 2.324, and 7.332 minutes respectively. The RP-HPLC approach was robust and accurate, so it is appropriate for repetitive assay of drugs and quality control. This method is effectively used for the assessment of marketable dosage form preparation. Keywords: RP-HPLC, Amoxicillin, Tinidazole, Omeprazole, Method Development, Method Validation