Formulation Of Dosage Forms Research Articles

Artificial Intelligence in Pharma

This paper aims to provide a better understanding of the possible applications of Artificial Intelligence (AI) in the field of Pharmacy. Artificial intelligence basically involves complex information processing. It enables machines to carry out certain functions which were originally done by human and which required human intellect. Over the past few years, the use of artificial intelligence in the pharma has grown unimaginably and is now able to revolutionize the way drugs are discovered and handled. AI is capable of impacting the field of pharmacy at multiple levels. Pharmacy and medical education, drug development, personalization of drug therapy, drug safety, rational drug use, manufacture and formulation of dosage forms are areas of impact by AI. The fact that AI can displace humans at their own tasks is a matter of concern. Although there are ethical concerns regarding the implementation of AI in healthcare, it can be assured that no machine or system can replace many of the humanitarian duties.

Isocratic high-performance liquid chromatography (HPLC) for simultaneous quantification of curcumin and piperine in a microparticle formulation containing Curcuma longa and Piper nigrum

Poor bioavailability has been reported as a major challenge in the development of curcumin as a pharmaceutical agent. However, co-administration of curcumin with piperine has been shown to improve curcumin bioavailability. Therefore, to assure product control quality, an analytical method needs to be developed for the determination of curcumin and piperine content in a dosage form formulation. The objective of this study was to develop a simple isocratic reversed-phase HPLC (RP-HPLC) method to simultaneously quantify curcumin and piperine content in solid dispersion based microparticle formulation containing Curcuma longa and Piper nigrum extracts. The method was validated according to the International Council for Harmonization (ICH) guideline. Chromatographic separation of three curcuminoids and piperine could be achieved using acetonitrile-methanol-water of 65:5:35 %, at a flow rate of 1 mL/min and a wavelength of 353 nm for detection. Resolution (Rs) of 3.57 and 1.68 for piperine and curcumin, respectively, a theoretical plate number (N) > 8000 and a tailing factor (T) < 1.5 indicate a satisfactory separation of the compounds. The calibration curve was linear from 1.25-15 μg/mL and 2.5–30 μg/mL for piperine and curcumin, respectively, with the correlation coefficient of >0.999. The intra-day/inter-day accuracy and precision demonstrated a recovery of 99.54–101.50%/99.38–99.89% and 100.78–102.51%/101.15–102.47% with a Relative Standard Deviation (RSD) of 0.53–0.95%/0.13–1.44 % and 0.28–1.62%/0.46–1.14% for piperine/curcumin. The limit of detection (LOD) were 0.27 and 0.42 μg/mL, for piperine and curcumin, which reveals an adequate sensitivity. A solid dispersion based microparticle formulation containing C. longa and P. nigrum extracts confirmed the validity of the developed method as a recovery of 91.14% and 99.14% for piperine and curcumin, respectively. In conclusion, all the tested parameters confirm the precision, accuracy, and reliability of the method for the simultaneous analysis of curcumin and piperine within a microparticle formulation containing C. longa and P. nigrum extracts.

Novel HPLC-UV method for simultaneous determination of valsartan and atenolol in fixed dosage form; Study of green profile assessment

Aim of this work was to develop the first simple, rapid, green, economical and selective HPLC method for simultaneous quantification of the cited drugs in their challenging binary mixture. The work was motivated by the global trends towards sustainable chemistry in designing eco-friendly mobile system without affecting the analysis parameters. The proposed method was subjected to a greenness profiles using some metrics as Eco-scale. Materials and methods. This was accomplished under the following chromatographic conditions: HPLC column Discovery C18 (4.6 mm i.d. × 150 mm, 5 μm), column temperature 30 °C, flow rate 1.0 mL/min, mobile phase composed of 20% acetonitrile, 80% of 0.16% ammonium acetate and 0.2% of 1.5 M tetramethylammonium hydroxide (V/V) and signal monitoring at a wavelength of 225 nm and 237 nm. Results. A conventional mixture of acetonitrile and 0.16% ammonium acetate was tried in different ratios, but the drugs were not well separated. The shortest aliphatic chain cationic ion pair reagent tetramethylammonium hydroxide should not be exchanged with other type similar with this, like tetramethylammonium hydrogen sulfate, it did not work to our experiments. Increasing salt concentration, ammonium acetate, more than 0.2%, pushes the peak of atenolol closer to dead volume, which is negative. Atenolol in their methods for multicomponent mixtures elutes in dead volume, or when retained longer, much stronger, hydrophobic mobile phase should be used if valsartan should be seen in same chromatogram at dissent time. The 237 nm can be chosen as compromise signal for nearly equal peaks height with high sensitivity is not essential. The 225 nm signal shows much higher sensitivity for atenolol and less increase for valsartan peaks, which can be used when higher sensitivities will be essential. Linearity was examined and proven at different concentration levels in the range of working concentration of valsartan (0.16–0.96 mg/mL) and atenolol (0.2–1.20 mg/mL). The high value of recoveries obtained for valsartan and atenolol indicates that the proposed method was found to be accurate. The results of proposed method found to be an excellent green analysis with a score of 84. Conclusion. A new fast, simple and green, but selective, accurate, precise and robust HPLC-UV method for simultaneous determination of valsartan and atenolol in newly formulated dosage form was developed and many possible variations of the same were suggested. The developed method for the simultaneous quantification of valsartan and atenolol in their challenging binary mixture offers simplicity essential for quality control of a large number of samples in short time intervals, which is necessary for routine analysis. The method was subjected to greenness profile assessment.

Favipiravir Effects on the Control of Clinical Symptoms of Hospitalized COVID-19 Cases: An Experience with Iranian Formulated Dosage Form.

Coronavirus disease -19 (COVID-19) pandemic, caused by SARS-CoV-2, has gradually spread worldwide, becoming a major public health event. This situation requires designing a novel antiviral agent against the SARS-CoV-2; however, this is time-consuming and the use of repurposed medicines may be promising. One such medicine is favipiravir, primarily introduced as an anti-influenza agent in east world. The aim of this study was to evaluate the efficacy and safety of favipiravir in comparison with lopinavir-ritonavir in SARS-CoV-2 infection. In this randomized clinical trial, 62 patients were recruited. These patients had bilateral pulmonary infiltration with peripheral oxygen saturation lower than 93%. The median time from symptoms onset to intervention initiation was seven days. Favipiravir was not available in the Iranian pharmaceutical market, and it was decided to formulate it at the research laboratory of School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. The patients received favipiravir tablet at a dose of 1600 mg orally twice a day for day one and then 600 mg orally twice a day for days 2 to 6. In the second group, the patients received lopinavir-ritonavir combination tablet at a dose of 200/50 mg twice a day for seven days. Fever, cough, and dyspnea were improved significantly in favipiravir group in comparison with lopinavir-ritonavir group on days four and five. Mortality rate and ICU stay in both groups were similar, and there was no significant difference in this regard (P = 0.463 and P = 0.286, respectively). Chest X-ray improvement also was not significantly different between the two groups. Adverse drug reactions occurred in both groups, and impaired liver enzymes were the most frequent adverse effect. In conclusion, early administration of oral favipiravir may reduce the duration of clinical signs and symptoms in patients with COVID-19 and hospitalization period. The mortality rate also should be investigated in future clinical trials.

Boron-doped diamond film and multiple linear regression-based calibration applied to the simultaneous electrochemical determination of paracetamol, phenylephrine hydrochloride, and loratadine in fixed-dose combinations

In this work, we employed multiple linear regression analyses to satisfactorily determine cold symptoms treatment drugs paracetamol, phenylephrine hydrochloride, and loratadine in pharmaceutical formulations with combined dosage and spiked human urine sample. All the drugs are irreversibly oxidized on the boron-doped diamond electrode (BDDE) in diffusion-controlled oxidation processes with well-separated potentials in acidic media. A square-wave voltammetric (SWV) method was developed for their simultaneous determination in 0.1 mol L–1 H2SO4 and simple and multiple linear regression analyses were compared as calibration methods for SWV data. Precision and selectivity were also studied. The high concentration ratio between paracetamol and the other two drugs being minor components in the formulated dosage forms caused interference in their voltammetric responses. An assay based on multiple linear regression equations considering these multiple effects revealed statistically the same results as those obtained by a comparative HPLC-UV method at a 95% confidence level. We demonstrated that multiple linear regression provided adequate recovery for the determination of PAR, PHE, and LOR in spiked human urine sample. The developed SWV method is a very fast, low-cost, and environmentally friendly alternative to the routine simultaneous analysis of PAR, PHE, and LOR performed by HPLC-UV.

Microemulsion systems: from the design and architecture to the building of a new delivery system for multiple-route drug delivery.

Poorly soluble active pharmaceutical ingredients (APIs) create major problems in drug dosage form formulation resulting in significant delays in drug pharmaceutical screening, impairing the drug dosage form production. Aiming to minimize the use of excipients for increasing drug apparent solubility and, as a result, its bioavailability, exploration of innovative approaches is an earnest need. Microemulsion is an alternative drug delivery system that emerged as a valuable tool to achieve safe formulations for insoluble compounds and to improve their biopharmaceutical properties and pharmacokinetics. This review aims to present the state of the art of microemulsion systems, bringing an overview about their origin and how they can be properly produced and thoroughly characterized by different approaches. Furthermore, comments on regulatory issues regarding stability assessment and toxicity evaluation are discussed. The review concludes with a current opinion on microemulsion systems. The overall objective of this work was to describe all the potentialities of microemulsion systems as a drug carrier for therapeutic purposes, highlighting the unique features of this nanotechnological platform. Display Image.

Medicinal Effect, In Silico Bioactivity Prediction, and Pharmaceutical Formulation of Ageratum conyzoides L.: A Review.

Goat weed (Ageratum conyzoides L.), or bandotan in Indonesia, is an herbaceous plant that broadly grows up in both subtropical as well as tropical areas. This herb contains many phytoconstituents which have many benefits in different aspects. The essential oil contains phytochemicals such as phenol, phenolic ester, and coumarin, whereas many compounds can been identified in the whole part such as terpenoid, steroid, chromene, pyrrolizidine alkaloid, and flavonoid. Empirically, this herb has been used as an antihemorrhagic, antiseptic, antileprosy, and wound-healing agent. This article reviews the potency of the herb in medication according to the chemical substances being deposited, which are collected from numerous studies, followed by its in silico bioactivity prediction as well as its pharmaceutical dosage form formulation.

A Laconic Review on Extraction, Biological Activities of Herbal Formulations of Berberine: A Traditional Drug

Herbal formulation dosage form consists of one or more herbs processed in specified quantities to provide specific nutritional, cosmetic benefits use to diagnose the disease. Herbal formulations contain an active substance and preparation in combination of one or more herbal compounds. Berberis aristata is one of herbs of an ancient Ayurveda medicine and different properties along with various treatment of illness. Berberine, is a type of alkaloid which is quarternary protoberberine, is one of the known bioactive compounds scattered extensively in a number of clinically significant medicinal plants such as Hydrastis canadensis L., Phellodendron amurense R. ,Coptis japonica M., and Berberine containing plants have been used in traditional and folk medicine around the globe for centuries. It has been used for a, anti-pyretic diarrhea, bitter tonic, and eye infections. In the past three eras, Berberine has been studied intensively in over thousands cases because of its therapeutics, physicochemical effects, pharmacological, and physiological effects such as cardiovascular, anti-inflammatory, anti leshmanial, and anti- secretory, effects. Berberine act as a phytoconstituents in formulations and available in ayurveda, allopathy, and homeopathy medicines. With this review, we will evaluate the various traditional and medicinal use of Berberine and their isolation and extraction procedure. We will also review the potential of this plant as various dosage forms for the treatment of various diseases.&#x0D; Keywords: Berberine; Extraction Method; Isolation method; Skin problems

Colon Targeted Protein Nanoparticles Loaded Suppositories : Effective against Intestinal Parasites.

Purpose: The aim of the present investigation was to formulate protein nanoparticles (PNPs) loaded suppositories for colon targeting of metronidazole (MZ), to achieve sustain release effect. Methods: PNPs were formulated via desolvation technique by utilizing 23 factorial design which results into eight formulations. The synthesized PNPs were characterized for different physicochemical and in vitro parameters viz. particle size, surface morphology, entrapment efficiency and zeta potential, drug- excipients compatibility studies.Results: The formulated PNPs were found to be spherical in shape and have an average size in the range of 300.7 nm to 504.8 nm. Based on the results obtained, F7 was found to be the optimized formulation that was loaded into the suppository base. Furthermore, suppositories were also characterized for several parameters like content uniformity, weight variation and liquefaction time.Conclusion: Resultant, suppositories were free from pits, fissures and cracks. The in-vitro release data of MZ-PNPs loaded suppositories were compared with the suppositories loaded with active ingredient only i.e. MZ. Screening against Pheretima posthuma was also conducted. The results of in vitro drug release testing proved that protein nanoparticle loaded suppositories is a better approach, compared to pure MZ loaded suppositories. Release kinetic study concluded that the formulation follows Higuchi’s equation i.e. having a biphasic release pattern. The efficiency of the formulated dosage form was evaluated using Indian earthworms, P. posthuma.

First FDA Approved 3D Printed Drug Paved New Path for Increased Precision in Patient Care

The pharmaceutical industry is developed every year with the aim of public health, safety, and financial growth. Keeping public safety in mind, the industry is mostly concentrated on novel plans in the drug development process and plans on how to increase the curing rate of a disorder and building up the accuracy in patient care. The increase in the number of diseases has led to the generic and branded drug competition by which the pressure on the market has increased. The pharmaceutical manufacturers are attempting to find the needs of patients in different ways. The industries were manufacturing the drugs in unique ways which help to increase their productivity and also to increase the patient experience. Due to this, all pharmaceutical manufacturers are trying to manufacture drugs using 3D printing. In 2015, the industries succeeded by manufacturing the drug Spritam using 3D printing and it was the first prescribed drug manufactured by using 3D printing (3DP). 3DP is the process of depositing powder in a layer upon layer that was opposite to subtractive manufacturing and it is perfect for pharmaceuticals because it provides enhanced accuracy in the development and formulation of dosage forms. The 3DP has different advantages to companies and patients like an increase in dissolution rate, absorption, adherence, efficacy, and long life of branded drugs along with the decrease in pill burden. This process leads to a break in the manufacturing method of drugs but helps to overcome several problems and also helps in better patient outcomes in the solid dose markets.

Fast disintegrating tablets of spray dried poly-herbal extract: a promising hypoglycemic and diabetic wound healing activity.

Many herbal products have been used to control blood glucose level and minimize complications of diabetes mellitus. However, the feasibility of using such herbal product has been hindered due to the lower stability of their extracts and patients incompliance. Objective: An optimized fast disintegrating tablet preparation of spray dried aqueous extract of poly herbal blend has been formulated to maximize the therapeutic activity of such herbal extract. Methods: different ratios of superdisintegrants were evaluated in terms of reducing disintegration time and wetting time of the prepared formulations. The potential of the optimized formula in reducing blood glucose level and promoting wound healing in STZ-induced diabetic rats was determined. Key finding: Oral administration of the optimized formula (F6) had significant superior effect in reducing blood glucose level and promoting wound healing of diabetic rats compared receiving the aqueous extract of the herbal blend (P<0.05, p<0.01, respectively). That may be attributed to the enhanced stability and the accurate dosing of such solid dosage form. In addition, no remarkable toxic manifestations or histologic changes were observed in treated animals. Conclusion: These findings uncover the potential of the formulated dosage form in enhancing the hypoglycemic and wound healing activity of the herbal extract.

Pharmacokinetic Evaluation of Flavonoid compound (acacetin) Isolated from Gmelina arborea roxb

Aim: The flavonoid compound (Acacetin) isolated from fruits of Gmelina arborea was investigated for its pharmacokinetic evaluation to find out the suitability of this compound to be formulated in any suitable dosage form. Method: The acacetin was administered intravenously and orally in Wistar rats at a dose of 2 and 10 mg/Kg body weight respectively. In a regular interval of specified time, blood samples were collected and bio-analyzed to quantify the drug concentration in the blood sample by using LC-MS. The Cmax, Tmax, T1/2, KE, Ka, and bioavailability (F) of acacetin were determined by mathematically and graphically from plasma concentration-time profile data. Absorption rate constant was determined by the method of residual. Results: From the i.v. Bolus administration data, acacetin had an area under curve (AUC) is 1.542 µg.h/ml, elimination rate constant (KE) is 0.423 h-1, and half-life (T1/2) is two hour. The oral administration of acacetin showed the peak plasma concentration (Cmax) of 1.668 µg/ml, Tmax is 1 h, AUC is 6.44 µg h/ml, KE is 0.416 h-1, T1/2 is 2 h, absorption rate constant (Ka) is 1.6 h and bioavailability of acacetin was found to be 84 %. Conclusion: From the study it could be concluded that the acacetin possessed relatively greater bioavailability; thus this drug exhibited significant satisfactory pharmacokinetic profile which would be helpful for successful designing of a suitable dosage form formulation.

Chemical and pharmaco-technological evaluation of Adjara region peat peloids

“Peloids” is an internationally recognized name of all kind medical muds. They are natural mixture of inorganic and organic materials and performs homogenous, finely dispersed mass with definite physical and chemical properties The effectiveness of peloids is due to high content of biologically active substances. High content of organic substances in peloids, such as chemically and biologically active organic carbon compounds formed by long-term chemical and microbiological processes, provides their application prospects in clinical practice. The objective of the research was evaluation chemical and pharmacotechnological properties of Adjara region Peat Peloids. The following tasks were to be solved to achieve the goal: Study chemical properties of Adjara region Peat Peloids; Determination spectrum of organic and inorganic substances; Formulation of nanocomposite containing sphagnum peat peloids; Formulation composition and development preparation technology of topical dosage form, plaster, containing nanocomposite of sphagnum peat peloids; Study antiinflammatory and antibacterial activity of peat peloids; The materilas of the research: sphagnum peat peloids of different ages (Ispani, Anaklia, Chirukhi, Peranga, Churia). Research strategy was to held experiments gradually from simple to complicated. Technological and biologic methods were used to solve research tasks. Research was held using modern instrumental methods of analysis&apparatus (UV spectrophotometer, Scanning Electron Microscopy, X ray fluorescence, Centrifuge, Dry oven, Ultraturax, AFM, XRD). It is estimated that Kolkheti sphagnum peat peloids contain a wide range of organic substances: humic acids, amino acids, fatty acids, carbohydrates and others. As a result of the research composition, design and preparation technology of plaster containing nanoconstructed system of sphagnum peat peloids is determined. Based on the research data Isapani sphagnum peat peloids and formulated dosage form (plaster) obtained anti-inflammatory action. Based on serial dilution (macro) method antibacterial activity of high concentration (1:1) sphagnum peat peloids (Ispani) was established.

Biowaivers-An updated Review

PURPOSE : A Biowaiver has been regarded as an official approval of the waiver for conducting a bioequivalence study in the context of an application for drug approval process. Bioequivalence is an important parameter in the process of drug development that is needed to be performed when there is a change in the formulation of dosage form. Approach : The approach of biowaivers is necessary to waive a complete and systemic Bioequalence study, which as a fast track approach to boost the drug development process. Findings : This review mainly discusses about the criteria for Biowaivers, requirements for a BCS based biowaiver study, conditions to grant the BCS based biowaiver, Applications, limitations, supporting data for Biowaivers. Conclusion : BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach.

POLYMER GRAFTING AND APPLICATIONS IN PHARMACEUTICAL DRUG DELIVERY SYSTEMS - A BRIEF REVIEW

Selection of proper polymer system is a critical step involved in the formulation of dosage form. Type of polymer/s incorporated in pharmaceutical formulation majorly decides the stability of formulation and drug itself, mechanism, and rate of drug release. Pharmaceutical and biological therapeutics are suffered from disadvantages such as short half-lives, poor bioavailability, and physical and chemical instability. Delivery of drugs to target site at a specific concentration for a specific time can be successfully achieved by the use of suitable polymer/s. Thus, it is not necessary that available polymer till the date should have all ideal properties with respect to above. This makes a demand of tailored polymers with desired features and introduces concept of grafting for making new polymers to be used in dosage forms. Grafting can be achieved by various techniques described herein and can be analyzed by various modern analytical techniques including infrared, NMR, X-ray diffractometer, and differential scanning calorimeter. These grafted polymers offer many applications in terms of site drug/biological carrying capacity, tailored physicochemical properties based dosage form modifications and with desired features, and also to deliver therapeutics at specific sites. Considering these advantages, a number of applications of grafted polymers developed and many patents were filed in this area till the date. This review highlights the basic concept of grafting and its various techniques and their significant pharmaceutical applications.

FORMULATION AND BIO-AVAILABILITY PARAMETERS OF PHARMACEUTICAL SUSPENSION

The suspension is a biphasic liquid or semi-solid dosage form where the finely divided insoluble solid drug particles are homogeneously dispersed in a liquid or semi-solid medium. The solid drug particles act here as the dispersed phase and the liquid or the semi-solid as the dispersion medium. Suspensions contribute to pharmaceutical dosage form development by supplying drugs that are insoluble in all acceptable medium and often distasteful. Suspension translates such drugs into more bio-available form when compared to capsules, tablets, coated tablets, enteric coated tablets and sustained release products. The dosage form is palatable to the patient and many are doing well when applied to the skin or mucous membrane. This particular dosage form is also applied for injecting drugs into the systemic circulation. Therefore, pharmaceutical suspension finds its application through three different routes of administration namely oral, externally applied suspension and injectable one. The success of any dosage form largely depends on formulation parameters and the factors that influence the bioavailability which ultimately dictate the therapeutic success of the formulated dosage form. Hence, it is obvious to discuss the formulation parameters and the factors influencing bioavailability of suspension for the therapeutic success of it.

Development and Validation of A Reversed Phase-High Performance Liquid Chromatography Method for the Quantitative Estimation of Ramipril Drug Content from Formulated Dosage Form

A reliable and reproducible reversed-phase high performance liquid chromatography (RP-HPLC) was developed for the quantitative determination of Remipril drug content from marketed bulk tablets. The active ingredient of Remipril separation achieved with C18 column using the methanol water mobile phase in the ratio of 40:60 (v/v). The active ingredient of the drug content quantify with UV detector at 215 nm. The retention time of Remipril is 5.63 min. A good linearity relation (R2=0.999) was obtained between drug concentration and average peak areas. The limit of detection and limit of quantification of the instrument were calculated 0.03 and 0.09 µg/mL, respectively. The accuracy of the method validation was determined 102.72% by recoveries method.

Effect of β-cyclodextrin on Rheological Properties of some Viscosity Modifiers.

Cyclodextrins are a group of novel excipients, extensively used in the present pharmaceutical industry. Sometimes they show significant interactions with other conventional additives used in the formulation of dosage forms. The effect of β-cyclodextrin on the rheological properties of aqueous solutions of some selected viscosity modifiers was studied in the present work. β-cyclodextrin showed two different types of effects on the rheology of the selected polymers. In case of natural polymers like xanthan gum and guar gum, enhanced apparent viscosity was found and in case of semi-synthetic polymers like sodium carboxymethyl cellulose and methyl cellulose, reduction in apparent viscosity was found. β-cyclodextrin was included at 0.5, 1 and 2% w/v concentrations into the polymeric solutions. These findings are useful in the adjustment of concentrations of viscosity modifiers during the formulation of physically stable disperse systems.

Simultaneous Formulation, Evaluation and Estimation of Self Emulsifying Drug Delivery System (SEDDS) of Ibuprofen Tablet Dosage form using Varied quantities of Goat Fat as an Excipient and Tween-60 as a Surfactant

The aim of present study confirmed that the SEDDS formulation can be used as a possible alternate to traditional or classical formulations of Ibuprofen to improve its bioavailability using varied quantities of goat fat as an excipient and tween 60 as a surfactant which is a drug in the nonsteroidal anti-inflammatory drug (NSAID) class used for treating pain, fever and inflammation which is also known to be isobutylphenylpropanoic acid. The investigation proved that the formulated dosage forms showed good release profile as well as acceptable tablet properties. The batches with higher tween60: goat fat content ratios gave better release rates. The SEDDS of Ibuprofen was successfully prepared and the tablets prepared passed the various evaluation tests conducted. This method has advantage of reliance on cheap raw materials such as goat fat with fewer processing steps, best suited for lipophilic drugs where the resulting emulsification gives faster dissolution rates and absorption. Invivo evaluation of this novel dosage form is currently in progress. Self-emulsifying drug delivery systems are a promising approach for the formulation of lipophilic drug compounds having poor aqueous solubility. The oral delivery of hydrophobic drugs can be made possible by SEDDSs which have been shown to improve oral bioavailability substantially. From the formulation point of view it is necessary to consider the emulsification properties of lipid base vehicle and the solubility of drug in the lipid surfactant mixture to form a completely miscible solution so as to solubilize adequate quantities of drug in lipid vehicle. Lipids have an important role in absorption process. Thus, SEDDS plays an important role in the formulation of poorly water soluble drugs and enhancing their bioavailability.

Development and Validation of a Stability Indicating HPTLC Method for Estimation of Artemether in Bulk and Formulated dosage form

A simple, sensitive and precise high-performance thin-layer chromatographic (HPTLC) method of analysis for artemether in bulk and prepared parental formulation was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: glacial acetic acid (9: 1: 0.5, v/v/v) as mobile phase. Densitometric analysis of artemether was carried out in the absorbance mode at 235 nm. The optimised chromatographic conditions gave compact spots for artemether (Rf value of 0.57 ± 0.03). The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9930 in the concentration range 4000-24000 ng per spot. The method was validated for precision, accuracy, recovery and robustness. The limits of detection and quantitation were 2101.5 and 3697.74 ng per spot, respectively. The proposed method was optimized and validated as per the ICH guidelines.