Karnataka

Many oral dosage forms, bulking agents and beverage products have unpleasant taste. The bitter taste is an undesirable trait of the product or formulations and can considerably affects its acceptability by consumer. So, they should be formulated in a palatable form. Bitter taste in such systems can be reduced or eliminated by various methods, but no universally applicable technologies are yet recognized. This article is about the discussion of recent approaches for minimizing the unpleasant taste for oral pharmaceuticals.   Key words: Taste masking, Eudragit.

The concept of controlled release tablet can be utilized to provide a long lasting and more reliable release of drug in GIT to ultimately develop a once daily formulation. Thus, they prolong the dosing intervals, but also increase patient compliance beyond the level of existing conventional dosage forms. Erythromycin, macrolide antibiotics is used in the treatment of Mycoplasma pneumoniae infections, Chlamydial infections, etc. It is a drug with short biological half-life 1.5 hrs and dosing frequency more than one per day which makes it an ideal candidate for controlled release. The present investigation was planned to formulate the Erythromycin stearate once daily controlled release tablets. The tablets were prepared by direct compression method and were subjected for in vitro drug release studies. The mechanism of drug release was determined using various kinetic models. The results revealed that all the formulated tablets had acceptable physical properties and showed release up to 24 hrs. The kinetic studies revealed that all the formulations followed Zero order release kinetics. The tablets were prepared by Direct Compression technique and evaluated for various parameters. The optimized formulation contains Erythromycin Stearate as active ingredient, HPMC K15M, Chitosan and Xanthan gum as rate retarding polymers.

The present study was carried out to monitor, estimate the prevalence and consequences of ADRs on treatment of TB and to assess causality, predictability, preventability and severity of the ADRs. A prospective observational and active surveillance study was conducted over a period of 9 months. Each reported ADR was assessed for its causality, severity, predictability and preventability as per standard algorithms. The management and outcome of ADRs were determined. A total of 128 ADRs (in 53 patients) were identified out of which the prevalence of ADRs in female was found to be 31.58% and 29.66% in male patients. The causality assessment by Naranjo’s scale showed that out of 128 ADR’s, 128 (100%) ADR’s were probable and based on WHO probability assessment scale 119(92.97%) were possible where as 9(7.03%) were probable. Preventability assessment showed that 125 (97.66%) were not preventable and 03 (2.34%) were definitely preventable. Severity Assessment by Modified Hartwig and Siegel Scale showed that 82 (64.06%) ADRs were mild and 46(35.94%) ADRs were moderate. 128(100%) were found to be predictable. Majority of the ADRs were recovered without giving symptomatic treatment. The study concluded that there is a need of a system for proper monitoring of ADRs caused by anti-TB drugs in RNTCP centre.  The counselling of patients for timely prevention, detection and management of ADRs will helps in further ADR occurrence minimisation.

Conventional drug therapy requires periodic doses of therapeutic agents. These agents are formulated to produce maximum stability, activity and bioavailability.  Floating drug delivery systems (FDDS) have a bulk density less than gastric fluids and so remain buoyant in the stomach without affecting gastric emptying rate for a prolonged period of time. While the system is floating on the gastric contents drug is released slowly at the desired rate from the system. The present study mainly focuses on the development and evaluation effervescent based floating matrix tablet of famotidine. This oral drug delivery offers several advantages over the standard conventional oral dosage forms. Effervescent based floating matrix tablet of famotidine was prepared using sodium bicarbonate as effervescent agent and by incorporating hydrophobic agent stearic acid which retards the drug release and allow the dosage form to float on gastric fluid for several hrs. Then the tablet was evaluated for hardness, friability, drug content and in vitro drug release. On the basis of the preliminary trials, a 32 full factorial design was employed to study the effect of independent variables, HPMC K4M: Carbopol 934P ratio (X1) and concentration of effervescent agent (X2) on dependent variables like floating lag time, Q4 and Q8. The best batch (F3) exhibited optimum floating lag time (16 sec), drug content (98.94%), Q4 (54.36 %), Q8 (93.98%) and similarity factor (83.92). The controlled release of famotidine was observed and good fit to the zero order was demonstrated.

Oxidative stress caused by free radicals is implicated in the pathogenesis of many diseases.  In order to continue the other plants with potential benefits with free radical scavenging properties, researchers start looking forward for exploring new plants with rich in flavonoids and polyphenolics. These constituents possess not only free radical scavenging properties but also they are highly safe in the treatment of many diseases/disorders. In one of the field survey, it was identified that Sesbania grandiflora(Linn) was extensively used by folklore practitioner for treating many human ailments such as flatulent-colic, astringent, cooling, bitter, tonic, anthelmintic, febrifuge, dyspepsia, diarrhea and gastralgia, pain, nyctalopia, anaemia, emaciation. Even the plant is a rich source of antioxidants such as phenolics and flavonoids. However, scientific information about the plant and concentration of these constituents was not updated. Hence it was planned to undertake the plant of the present study for its spectrophotometric determination of total phenolic and flavonoid contents from 70% alcoholic extract of flowers of Sesbania grandiflora using Catechol and Quercetin as reference standard. It was observed that, 70% alcoholic extract of flowers of Sesbania grandiflora(Linn) showed 64.0mg/G of total phenol equivalent to catechol and 28.80mg/G of flavonoidal content equivalent to quarcetin standard.  Hence it may be concluded that the plant many be potential source of antioxidant principles such as phenolic and flavonoid. Furthermore, the plants possessing these antioxidants can be highly beneficial for the treatment of many common human ailments. Key-Words: Catechol, Flavonoid, Phenolic, Quercetin, Sesbania grandiflora(Linn).

Delonix regia, a well known plant with high medicinal value, reported to have a number of biological activities including antioxidant, and presence of flavonoids in its chemical constituents. Antioxidant property and flavonoids have been associated with wound healing actions of plants. The present study was done to investigate the wound healing properties of Delonix regia in experimental animal models. The ethanolic and aqueous extracts of Delonix regia flowers were prepared to study the effect on wound healing in albino rats using incision and excision wound models. Healing was assessed by the rate of wound contraction, period of epithelialisation, tensile strength (skin breaking strength) and estimation the hydroxyproline content. The extracts significantly promoted the healing process, as evident by an increase in wound breaking strength, percentage of wound contraction, increased hydroxyproline content and decreased epithelialisation period, suggesting the possible utilization of this plant to enhance wound healing. Key words: Delonix regia, flowers, extract, wound.

  The goal of present investigation highlights the formulation and evaluation of mucoadhesive buccal patches of Tramadol hydrochloride. The mucoadhesive buccal patches of Tramadol hydrochloride were prepared by solvent casting technique using various concentrations of Chitosan polymer. The formulated patches were evaluated for their physicochemical parameters like thickness, weight variation, surface pH, content uniformity, folding endurance swelling percentage studies and in vitro residence time. In vitro release studies were performed with pH 6.8 phosphate buffer solution. Good results were obtained both in physicochemical and in vitro studies. The films were exhibited controlled release more than six hours. The in-vitro release datas were fit to different equation and kinetic models to explain release profiles. The best mucoadhesive performance and matrix controlled release was exhibited by the formulation R6. The formulation was found be right and suitable candidate for the formulation of Tramadol HCL mucoadhesive buccal patches for therapeutic use. Key words: Tramadol HCL, Chitosan, Mucoadhesive buccal patches, PVP K-30.

The family of Rutaceae contains extremely wide variety of aromatic plants, mainly in tropical regions. Among them the rich is the genus Ruta. It is now cultivated in many parts of the world. This plant is considered indigenous in South Europe and North Africa and it grows on waste stony ground. Rue (Ruta graveolens) has been used for centuries as a medical preparation and has a variety of roles, probably because of its varied chemical composition. This plant is commonly cultivated in India and is commonly called as sudab or sadab. In traditional system of medicine it is used as stimulant, emmenagogue, diuretic, abortefacient, and resolvent. Detailed and comparative studies from its traditional use especially with reference to Unani system of Medicine, to the modern scientific reports have been evaluated in this paper. Keywords: Sudab; Ruta graveolens; Unani system of Medicine; Flavonoid.

Biomarkers and surrogate endpoint largely replaced the clinical trials which are needed to be carried out before drug approval in regular approval process under FDA (Food and Drug Administration), a governing pharma regulatory body in USA and as a result approval process can be accelerated. It can be said that surrogate endpoint and biomarker are substituting the clinical trials and decrease the duration of product development phase as well as decrease the entry time period of novel products in the market. The article enlightens the extent to which the biomarkers and surrogate endpoint have benefited the pharma industry for expediting the entry of their products into the market at the earliest to get the maximum benefit of the product during the patent period. Simultaneously article also throws light on the history of risk factors of surrogate endpoint which are likely to jeopardize the interest of the human beings involved. It may conclude that Biomarkers and surrogate endpoints play pivotal role in accelerating approval process for drug approval in USA and the usage of these parameters to minimize the casualty of human lives who are suffering from serious life threatening diseases by providing recent research products which have caliber to cure or improving the quality of life. Key words: Clinical trial, Biomarker, Surrogate end point, Accelerated approval, Caliber to cure, Casualty of human lives.

It is well known that solid oral dosage forms, particularly tablets, are the most acceptable form of delivering medication. However, some new variations are beginning to emerge such as mini-tablets, which offer formulation flexibility. A multifunctional and multiple unit system for oral use are developed by filling versatile mini-tablets in a hard capsule. Multipulsatile DDS, site-specific DDS, zero-order DDS, slow/quick DDS, and quick/ slow DDS are designed in different ways and are investigated. Mini-tablets are small tablets with a diameter typically equal to or less than 3 mm that are typically filled into a capsule, or occasionally, further compressed into larger tablets. It is possible to incorporate many different mini-tablets, each one formulated individually and programmed to release drug at different sites within the gastrointestinal track, into one capsule. These combinations may include immediate release, delayed release, and/or controlled release mini-tablets. It is also possible to incorporate mini-tablets of different drugs to treat concurrent diseases or combinations of drugs to improve overall therapeutic outcome, while delivering distinct release rates of each according to disease requirements. Mini-tablets combine the advantages of multiparticulate dosage forms with the established manufacturing techniques of tableting. Additional benefits of mini-tablets include excellent size uniformity, regular shape and a smooth surface, thereby offering an excellent substrate for coating with modified release polymeric systems. From this, study it can be concluded that, granules-mini-tablets filled in HPMC capsule systems and coated mini-tablet-in-HPMC capsule system sulphate shows both sustained release as well as immediate release may improve the bioavailability and efficacy of any drugs. Keywords: Mini-tablets, immediate-release, delayed-release, controlled-release, multiparticulate dosage forms.