DRUG EXCIPIENT COMPATIBILTY STUDY NISARG PATEL DEPARTMENT OF PHARMACEUTICS & Study of drug-excipient compatibility is an important phase in the pre-formulation stage of drug development. drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage. Clipping is a handy way to collect important slides you want to go back to later. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. Excipients 1. Studies of drug-excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. If you continue browsing the site, you agree to the use of cookies on this website. Drug-excipient compatibility study is a necessary prerequisite to the development of drug products that are safe and stable for use. By performing DECS we can know the possible reaction before formulating final dosage form. This method of analysis is used to characterize pharmaceutical solid to obtain heats of solution, heats of crystallization, heats of reaction, heats of dilution and heats of adsorption – since nearly all physicochemical processes are accompanied by a heat exchange within their surroundings. In a typical drug-excipient compatibility experiment, drug stability at accelerated temperature was assessed in the presence of single or multiple excipients (either as powder blend or as compact) with or without humidity/water [ 13] - [ 16]. Customer Code: Creating a Company Customers Love, No public clipboards found for this slide. Proper selection and assessment of possible incompatibilities between the drug and excipients during preformulation studiesis of paramount importance to accomplish the target product profile and critical quality attributes. Hence, the present study was aimed to assess the interaction of curcumin with excipients used in nanoformulations. oSolution of Drug, Excipient & Drug: Excipient mixture are prepared & spotted on the same baseline at the end of plate. In the typical drug–excipient compatibility testing program, binary powder mixes are prepared by … SEMINAR ON DRUG EXCIPIENT COMPATIBILTY STUDY (As a part of preformulation study) 1 2. Goal of drug-excipients compatibility study: • 1.To find out the excipients that are incompatible with the API • 2.To find out that excipients do not have any impact on the stability of the API • 3.To find out the excipients that can stabilize the unstable API • 4.To assign a relative risk level to each excipients within a functional • 5.To design and develop selective and stability-indicating analytical … Drug-Excipients compatibility studies. Solution of Drug, Excipient & Drug: Excipient mixture are prepared & spotted on the same baseline at the end of plate. Kinjan Mehta. For products that contain more than one drug substance, the compatibility of the drug substances The potential interactions between drugs and excipients have effects on the chemical, physical, bioavailability and stability of the dosage form. The potential physical and chemical interactions between drugs and excipients can affect the chemical, physical, therapeutical properties and stability of the dosage form. introduction,objective,types,advantages, instuments used of compatibility study. oStationary Phase consist of powder (Silica, Alumina, Polyamide, Cellulose & Ion exchange resin) adhered onto glass, plastic or metal plate. The potential physical and chemical interactions between drugs and excipients can affect the chemical, physical, therapeutical properties and stability of the dosage form. 1. See our User Agreement and Privacy Policy. The AAPS Journal, Vol. However, there are several well documented mechanisms in the literature. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Excipient selection also depends on various routes of administrations. Now customize the name of a clipboard to store your clips. ☻Importance of Drug Excipient Compatibility Study:- Stability of the dosage form can be maximized. Preformulation testing involved investigation of physical and chemical properties of a drug substance alone and when combined with excipients. Drug-Excipient Compatibility Studies in Formulation Development: Current Trends and Techniques . BY: The objectives of drug–excipient compatibility studies is to find out interactions between potential formulation excipients and the API, thus allowing the rapid optimisation of a particular dosage form with respect to patentability, processing, drug release, elegance, and physical and chemical stability. It was the first step in the rational development of dosage forms. In order to avoid stability problems encountered during drug development and post-commercialization, there is need for proper assessment of possible incompatibili… [23] Some incompatibilities of drug sub-stance functional groups and excipients are documen-ted in the literature and can provide guidance in the design phase of compatibility studies. PREPARED BY In order to consistently maintain these attributes in a finished dosage form, it is Drug Solubility studies in different solvents used [If Drug is in solubilized form]. The safety, efficacy, quality and stability of a formulation are the cornerstones of any new drug development process. It helps to understand the selections of suitable excipients, appropriate formulation composition, proper primary packaging material and suitable storage condition of … 15, No. Drug solution stability studies for atleast 24 hours. However, unfavourable combinations of drug-drug and drug-excipient may result in interaction and rises the safety concern. This study was carried out to detect any change on chemical constitution of the drug after combination with the β-Cyclodextrin in the ratio (1:1). Studies of drug–excipient compatibility represent an important phase in the development of all dosage forms. TLC AND HPTLC oTLC is generally used as confirmative test of compatibility after performing DSC. 1. Alternatively, thermal analysis … API characterization 2. -Mixture should be examined under N 2 to eliminate oxidative and pyrrolytic effects at heating rate ( 2, 5 or 100 c / min) on DSC apparatus. Drug-excipient compatibility is a key stage for the development of well planned, robust, safe, stable and bio-available drug product. Looks like you’ve clipped this slide to already. If you continue browsing the site, you agree to the use of cookies on this website. S.P. PHARMACEUTICAL TECHNOLOGY -The preformulation screening of drug-excipient interaction requires (1 : 1)Drug:excipient ratio, to maximize the likehood of observing an interaction. to identify drug excipients compatibility as a part of formulation development process [4]. The functional groups within the drug molecule may change the activity of each other, hence alters the therapeutic affectivity [5,6]. The drug-excipient compatibility studies were carried out with the possible excipients viz. This type of study is generally named an excipient compatibility study and requires a mixture experiment. The present review focuses on the techniques for compatibility screening of active pharmaceutical ingredient with their potential merits and demerits. To confirm and complete the DSC results, the compatibility studies were further conducted using FTIR-spectroscopic method. This work exemplifies a general method of studying the drug excipient interactions, with the aim of predicting rapidly and inexpensively the long term stability of their mixtures. 39,41 The addition of water allows the pH of the drug–excipient blend and the role of moisture to be investigated. Drug.excipient.compatibility 1. The thermogram of mixture is depicted in figure 6. 4. Sci 124 New Lab Chromatographic Separation Methods, high performance thin layer chromatography, No public clipboards found for this slide, Student at Columbia Institute of Pharmacy Raipur. this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly. Looks like you’ve clipped this slide to already. Drug–excipient mixtures were blended for 2 min at ∼1500 rpm, while changing direction of rotation every 30 s, on the microplate shaker, sealed if necessary, and placed under accelerated stability at 40 °C/75% relative humidity for 1–4 weeks. Journal of Thermal Analysis and Calorimetry, Vol. The DECCAS performed the drug–excipient chemical compatibility study design outlined in Table 1, following the work flow depicted in Fig. consist of powder (Silica, Alumina, Polyamide, Cellulose & Ion exchange resin) adhered onto glass, plastic or metal plate. 73 (2003) 547–561 DRUG–EXCIPIENT COMPATIBILITY STUDIES BY PHYSICO-CHEMICAL TECHNIQUES The case of atenolol A. Marini 1*, V. Berbenni 1, M. Pegoretti 1, G. Bruni 1, P. Cofrancesco 1, C. Sinistri 1 and M. Villa 2 1 C.S.G.I., Dipartimento di Chimica Fisica M. Rolla, Via Taramelli 16, 27110 Pavia, Italy 2 Dipartimento di … You can change your ad preferences anytime. COLLEGE,SALVAV-VAPI We study the physico-chemical properties of a drug (indomethacin) in the solid state and in different combinations with several excipients (PVP=polyvinylpyrrolidone, MGST=magnesium stearate, Avicel©). 3.7 Drug β-Cyclodextrin compatibility studies by DSC Compatibility of the drug with excipients was determined by DSC analysis. The routine drug-excipient interactions can be … SMT.BNB SWAMINARAYAN PHARMACY COLLEGE,VAPI 1. oThe plate is then … PREFORMULATION STUDIES. The compatibility of the drug substance with excipients listed in 3.2.P.1 should be evaluated. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Studies of drug-excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. (M.PHARM-SEM-I) The SEMINAR ON A crucial stage in the development of medical drugs is to study which additives, usually called excipients, impact the active ingredient stability. These studies are categorised as under: 1. TLC & HPTLC TLC is generally used as confirmative test of compatibility after performing DSC. excipients (where the excipient does not chemically interact but promotes the degradation of the drug substance). It helps to avoid the surprise problems. Excipient compatibility tests allows us to determine drug excipient interactions which can be either avoided or can be modified to utilize in an efficient manner which helps in minimizing the risk associated with the excipients. COMPATABILITY STUDIES DRUG EXCIPIENTS SMT.B.N.B SWAMINARAYAN PHARMACY We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. In a typical drug-excipient compatibility study, a solution, suspension, or solid mixture of drug … 1, January 2013 4 GENERIC DEVELOPMENT OF TOPICAL DERMATOLOGIC PRODUCTS Formulation Design: Initiation of Generic Drug Product Development: Development with Q1/Q2 sameness. Abstract . Drug-excipients interaction occurs more frequently than excipient-excipient interaction (Pifferi et al., 2003; Cavatur et al., 2004). See our Privacy Policy and User Agreement for details. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. For products that contain more than one drug substance, the compatibility of the drug substances with each other should also be evaluated. Any physical or chemical interaction between drug and excipient can affect bioavailability and stability of drug. Tween 80, Carbopol 940, chitosan, sodium alginate, and polycaprolactone (PCL) for their possible use in the formulation of eugenol loaded nanoemulsion gels and nanoparticles. The potential physical and chemical interactions between drugs and excipients can affect the chemical, physical, therapeutical properties and stability of the dosage form. Excipient An excipient is an inactive substance formulated alongside the active ingredient of a medication, for the purpose of bulking-up formulations that contain potent active ingredients. Drug-Excipient Compatibility Studies. Mechanism of drug-excipients interaction Exact mechanism of drug excipients interaction is not clear. Methods: Isothermal stress testing method was used to assess the compatibility of drug-drug/drug-excipient. The compatibility of the drug substance with excipients listed in 3.2.P.1 should be evaluated. The plate is then placed upright in a closed chamber … Further, the review highlights the applicability of these techniques using specific drug-excipient compatibility case studies. Studies of drug-excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. Now customize the name of a clipboard to store your clips. Drug products contain both drug substance (commonly referred to as active pharmaceutical ingredient or API) and excipients. Typically, a drug substance/excipient compatibility study is performed with binary mixtures which are prepared in the presence/absence of added water, stored at accelerated conditions, and then analyzed by stability-indicated methodology, such as HPLC. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. If you continue browsing the site, you agree to the use of cookies on this website. Clipping is a handy way to collect important slides you want to go back to later. See our User Agreement and Privacy Policy. (As a part of preformulation study) See our Privacy Policy and User Agreement for details. You can change your ad preferences anytime. INTRODUCTION 2 • INCOMPATIBILITY -Definition -3 Types • OBJECTIVE OF THE STUDY -Why to screen excipients? If you continue browsing the site, you agree to the use of cookies on this website. The the compatibility of the dosage form can be maximized and demerits Alumina Polyamide. Groups within the drug with excipients of a clipboard to store your clips DSC results, present... Final dosage form can be maximized plastic or metal plate rises the safety concern however there! Are several well documented mechanisms in the literature, 2004 ) to screen?! This website the the compatibility of the drug molecule drug excipient compatibility studies slideshare change the activity of each other should also evaluated... 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