Pharmaceuticals can be used in un-approved or unlicensed indications or dosages apart from their licensed use. This is called off-label use. In principle, a drug can be considered to be off label under three conditions: (i) if the approval have not been extended, although evidence of efficacy is available; (ii) if it falls into the so-called ‘grey zone’ of evidence-based medicine, within which ...

The following is a review of the literature that addresses the use of cyclodextrin in solid dosage forms. Care was taken to exclude physical and chemical characteristics of cyclodextrin, which have been discussed in the literature. A flow diagram is provided to outline the decision-making steps that are involved in the development process. Both preparation of physical mixtures and inclusion com...

There is no approved comparator list in Mongolia. The innovator pharmaceutical product is usually the most logical comparator product for a multisource pharmaceutical product because its quality, safety and efficacy should have been well assessed and documented in premarketing studies and postmarketing monitoring schemes. There are registered 65 products in Mongolia, containing Paracetamol, and...

BACKGROUND A lack of age-appropriate formulations can make it difficult to administer medicines to children. A manipulation of the dosage form may be required to achieve the required dose. This study aimed to describe medicines that are manipulated to achieve the required dose in paediatric practice. METHOD A structured, undisguised observational study and postal survey. The observational stu...

Buprenorphine is a partial mu agonist and kappa antagonist which is used for the treatment of pain and opioid addiction. A mixture of buprenorphine hydrochloride and naloxone hydrochloride has been approved for the treatment of opioid dependence.In this study a third order derivative spectrophotometric method based on zero-crossing technique has been used for the simultaneous determination of b...

Three rapid spectrophotometric methods were developed for the determination of sunitinib based on the formation of ion-pair complex in acidic medium with bromocresol purple, bromothymol blue, and bromophenol blue. The formed ion-pair complexes, extractable with chloroform, were measured at 422 nm for bromocresol purple, 425 nm for bromothymol blue and 427 nm for bromophenol blue. All these meth...

Drug dosage forms contain many components in addition to the active pharmaceutical ingredient(s) to assist in the manufacturing process as well as to optimise drug delivery. Due to advances in drug delivery technology, excipients are currently included in novel dosage forms to fulfil specific functions and in some cases they directly or indirectly influence the extent and/or rate of drug releas...

Fluvoxamine maleate is a selective serotonin reuptake inhibitor, which is used for the treatment of different types of depressive disorders. In the present study, a stability indicating HPLC method was developed and validated for the determination of fluvoxamine maleate. The chromatographic separation was carried out using a Nova-Pak CN column and a mixture of K2HPO4 50 mM (pH 7.0) and acetonit...

a simple and reliable stability-indicating rp-hplc method was developed and validated for analysis of adefovir dipivoxil (adv).the chromatographic separation was performed on a c18 column using a mixture of acetonitrile-citrate buffer (10 mm at ph 5.2) 36:64 (%v/v) as mobile phase, at a flow rate of 1.5 ml/min. detection was carried out at 260 nm and a sharp peak was obtained for adv at a reten...

fluvoxamine maleate is a selective serotonin reuptake inhibitor, which is used for the treatment of different types of depressive disorders. in the present study, a stability indicating hplc method was developed and validated for the determination of fluvoxamine maleate. the chromatographic separation was carried out using a nova-pak cn column and a mixture of k2hpo4 50 mm (ph 7.0) and acetonit...