Formulation and Evaluation of Oral dispersible Tablet of Paroxetine Hydrochloride

Orodispersible tablets (ODTs) is one such novel approach which helps to increase user acceptance by virtue of rapid disintegration, self-administration without water or chewing. ODTs are solid unit dosage forms like the conventional tablets containing super disintegrants, which help them to disintegrate and/or disperse rapidly in the mouth within few seconds. The orodispersible tablet of Paroxetine hydrochloride was prepared by using direct compression method and the tablet were formulated using various concentration of Kyron T-314 as disintegrating agent, PVP K-30 as binder, F melt Type C as diluent, Sodium Saccharin as sweetening agent, talc as lubricant and Aerosil as glidant respectively. All the batches were prepared according to Factorial design. The prepared tablets were evaluated for various parameters like hardness, dissolution, friability, weight variation, disintegration time. Batch F5 was found to be the best batch as the disintegration time is minimum (26seconds) and better drug release profile. Orodispersible tablets of Paroxetine Hydrochloride were successfully formulated by which first pass metabolism could be avoided and faster onset of action could be achieved.

Simultaneous Spectrophotometric Estimation of Paroxetine Hydrochlorides and Clonazepam in Bulk and Tablet Dosage Form

Two novel simple, accurate and precise spectrophotometric methods have been developed for quantitative estimation of Paroxetine hydrochloride and Clonazepam in the tablet dosage form. The standard stock solution was prepared by using the solvent methanol and further dilutions were carried out by using 0.1 N HCl. The method I is Vierodt’s Simultaneous method in which 291.60nm and 272.27nm was selected for estimation of Paroxetine and Clonazepam respectively, while method II is Absorbance Correction method, where 325 nm and 291nm was selected for estimation of Paroxetine hydrochloride and Clonazepam respectively. The calibration curve was plotted of the concentration range of 0.5-30μg/ml for both the drugs. Both the drugs obeyed Beer’s law in the concentration range 0.5-30μg/ml, correlation coefficient (r2<1). The precision of both the methods was found satisfactorily. The values of relative standards were not more than 2%. Both methods were validated statistically and recovery studies were carried out to confirm the accuracy. Commercial tablet formulation was successfully analyzed using the developed methods. Both these methods can be used for routine analysis for the estimation of Paroxetine hydrochloride and Clonazepam in the combined formulation. Due to the high sensitivity and simple sample preparation, the methods described can be used for undergraduate studies. Hence simple spectrophotometric methods have more advantages over sophisticated instrumental analysis such as HPLC. Hence these two simple and economical, instrumental methods always have a role in pharmaceutical analysis.

Polymorphism and patents

A brief introduction to patents is followed by a discussion of the two main issues of patents on (pharmaceutical) polymorphs from the scientific perspective: novelty and obviousness, with an emphasis on the latter. The issues, decisions, and ramifications of six landmark patent litigations involving solid forms are described. These involved the following drugs: cefadroxil, terazosin hydrochloride, ranitidine hydrochloride, paroxetine hydrochloride, armodafinil, and tapentadol hydrochloride. The chapter closes with a description of the litigation on the synthetic sweetener aspartame which involved an issue of habit (shape) rather than the form (crystal structure).

Paroxetine Hydrochloride Push-pull Osmotic Pump Tablets: Designing an Innovative, Scalable Push-pull Osmotic Drug Delivery System Using QbD Approach

Background: Paroxetine hydrochloride hemihydrate (PHH) is a serotonin reuptake inhibitor useful for the treatment of diverse psychiatric problems. Existing marketed formulations with frequent administration lead to gastrointestinal (GI) reactions and abrupt fluctuations in plasma level with poor patient compliance. These prerequisites are sufficed by controlled release push-pull osmotic pump tablets (PPOP). Objective: Objective of the present study was to develop robust and reliable PPOP formulation via Quality by design (QbD) approach to achieve desired release kinetics. Methods: PPOP was formulated using wet granulation method followed by osmotic coating. QbD strategy for defining the risk assessment of influential variables such as swelling polymers and osmogen on in vitro release kinetics of designed PPOP. Results: Presence of Polyox in push and pull layer along with osmogen controlled the drug release pattern from formulated PPOP system as depicted in 33 factorial design. These formulated optimized PPOP systems demonstrated 2 hrs lag time with zero-order kinetics, a peculiar feature of PPOPs. Conclusions: Scalable, stable PPOP tablets were fabricated by applying systematic QbD approach. The developed PPOP systems with improved concentration-independent behavior helped to address the challenges of existing marketed formulations. Risk mitigation and control strategy assured quality of the system during scalability. Application of QbD strategy in establishing the PPOP formulation would help in formulating drug candidates having gastric limitations and poor patient compliance. The present study is the detailed account of QbD based PPOP formulation, therefore it can be of potential importance from academics as well as industrial perspective.