QbD Approach to Formulation Development for a Suspension Based Soft Gelatin Dosage Form

2016 ◽  
Author(s):  
Saujanya Gosangari
Keyword(s):  
Dosage Form ◽  
Formulation Development

Nevirapine Pharmaceutical Cocrystal: Design, Development and Formulation

2019 ◽  
Vol 9 (3) ◽  
pp. 240-247
Author(s):  
Prabhakar Panzade ◽  
Priyanka Somani ◽  
Pavan Rathi
Keyword(s):  
Dosage Form ◽  
In Vitro Dissolution ◽  
Soluble Form ◽  
Ir Absorption ◽  
Stoichiometric Ratio ◽  
Design Development ◽  
Formulation Development ◽  
Scanning Calorimetry ◽  
Absorption Bands ◽  
Pharmaceutical Cocrystal

Background and Objective: The top approach to deliver poorly soluble drugs is the use of a highly soluble form. The present study was conducted to enhance the solubility and dissolution of a poorly aqueous soluble drug nevirapine via a pharmaceutical cocrystal. Another objective of the study was to check the potential of the nevirapine cocrystal in the dosage form. Methods: A neat and liquid assisted grinding method was employed to prepare nevirapine cocrystals in a 1:1 and 1:2 stoichiometric ratio of drug:coformer by screening various coformers. The prepared cocrystals were preliminary investigated for melting point and saturation solubility. The selected cocrystal was further confirmed by Infrared Spectroscopy (IR), Differential Scanning Calorimetry (DSC), and Xray Powder Diffraction (XRPD). Further, the cocrystal was subjected to in vitro dissolution study and formulation development. Results: The cocrystal of Nevirapine (NVP) with Para-Amino Benzoic Acid (PABA) coformer prepared by neat grinding in 1:2 ratio exhibited greater solubility. The shifts in IR absorption bands, alterations in DSC thermogram, and distinct XRPD pattern showed the formation of the NVP-PABA cocrystal. Dissolution of NVP-PABA cocrystal enhanced by 38% in 0.1N HCl. Immediate release tablets of NVP-PABA cocrystal exhibited better drug release and less disintegration time. Conclusion: A remarkable increase in the solubility and dissolution of NVP was obtained through the cocrystal with PABA. The cocrystal also showed great potential in the dosage form which may provide future direction for other drugs.

scholarly journals FORMULATION DEVELOPMENT AND EVALUATION OF GASTRO-RETENTIVE DOSAGE FORM OF ATAZANAVIR SULPHATE

2018 ◽  
Vol 10 (1) ◽  
pp. 60
Author(s):  
Hemant Kumar Jain ◽  
Madhuri Taware
Keyword(s):  
Solid Dispersion ◽  
Dosage Form ◽  
In Vitro Release ◽  
Hplc Method ◽  
Phase Solubility ◽  
Dissolution Profile ◽  
Formulation Development ◽  
Peg 6000 ◽  
Phase Solubility Study ◽  
Gastro Retentive

Objective: To improve dissolution properties of atazanavir sulphate by preparing gastro-retentive granules by solid dispersion method and development of RP-HPLC method for estimation of this drug.Methods: Estimation of atazanavir sulphate was done using high performance liquid chromatography (HPLC) on inertsil column (5 µm, 250x4, 6 mm) with a mobile phase consists of methanol: water (91:9 v/v), at 0.5 ml/min flow rate and 249 nm UV detection. The method was validated as per ICH guidelines. Selection of the carrier for gastro-retentive formulation was based on phase solubility study of the drug. Solid dispersions of gastro-retentive granules of different composition of drug and carrier, were prepared by the kneading, heating and solvent evaporation. A 32factorial design was applied to optimize the gastro-retentive formulation. The amounts of polyethylene glycol 6000 (PEG 6000) (X1) and hydroxypropyl methyl cellulose (HPMC) (X2) were selected as independent variables and in vitro-release at 5, 9 h and total floating time was selected as dependent variables. Results: HPLC method was found to be linear in a concentration range of 10-60 μg/ml of the drug (r2= 0.999). The low value of % RSD in precision study indicates reproducibility of the method. The low value of LOD and LOQ suggests the sensitivity of the method. The solubility enhancement study of drug with various carriers followed descending order of solubility [Gelucire 44/14>PEG 6000>polyvinyl pyrrilidone (PVP)]. Highest % cumulative release was observed for the heating method at drug polymer (PEG 6000) ratio 1:5. Hence, this ratio has been selected for preparation of solid dispersion. From comparison of dissolution profile of formulated batches, formulation F4 [containing PEG6000 (1.6 g) and HPMC (200 mg)] showed promising dissolution parameters with desired floating properties.Conclusion: Results obtained by validation studies suggested that the developed HPLC method is simple, accurate, precise and can be used for routine analysis of atazanavir sulphate formulation. Results of evaluation of prepared batches indicate that batch F4 is a promising formulation for gastro-retentive dosage form of drug. 

scholarly journals SPLIT-HALF TABLETS: A COMPLETE REVIEW FOR ANALYTICAL TESTING

2019 ◽  
pp. 27-38
Author(s):  
LAKSHMI NARASIMHA RAO KATAKAM
Keyword(s):  
Dosage Form ◽  
Drug Product ◽  
Analytical Techniques ◽  
Quality Attributes ◽  
Oral Dosage ◽  
Analytical Evaluation ◽  
Formulation Development ◽  
Analytical Methodology ◽  
Acceptance Criterion ◽  
Solid Oral Dosage Form

A solid oral dosage form (as a tablet) which is an immediate or extended-release dosage form which necessitates the scoring bisect of the tablet. This review discusses the quality attributes and interpretations for the split studies of the various tablet formulations using the analytical techniques. Each method of analysis for the evaluation of split-half tablets in terms of its critical quality attributes discusses in detail explanation of analytical methodology and challenges in formulation development. The results for quantitative analytical evaluation in terms of finished product/stability testing and release of the split-half drug product against the acceptance criterion and also discusses the flowchart guidance for the investigation of out of specification results. The present article provides an insight into the complete analytical evaluation of split-half drug product testing according to the requirements of tablet scoring as per US food and drug administration.

scholarly journals Stability Indicating Liquid Chromatographic Method for Estimation of Trihexyphenidyl Hydrochloride and Risperidone in Tablet Formulation: Development and Validation Consideration

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Patel Bhaumik ◽  
Gopani Mehul ◽  
Vikani Kartik ◽  
Patel Rashmin ◽  
Patel Mrunali
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Calibration Plot ◽  
Simultaneous Estimation ◽  
Formulation Development ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

This paper describes validated reverse phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of trihexyphenidyl hydrochloride (THP) and risperidone (RSP) in the pure powder form and in combined tablet dosage form. The HPLC separation was achieved on a core shell C18 (100 mm length × 4.6 mm, 2.6 μm particle size) using methanol : ammonium acetate buffer 1% (85 : 15 v/v; pH-6.5) as mobile phase and delivered at flow rate of 0.8 mL/min. The calibration plot showed good linear relationship with r2 = 0.997 ± 0.001 for THP and r2 = 0.998 ± 0.001 for RSP in concentration range of 50–175 μg/mL and 50–175 μg/mL, respectively. LOD and LOQ were found to be 0.40 and 1.29 μg/mL for THP and 1.24 and 3.92 μg/mL for RSP. Assay of THP and RSP was found to be 100.16 ± 0.03% and 99.83 ± 0.02%, respectively. THP and RSP were subjected to different stress conditions (acidic, basic, oxidative, thermal, and photolytic degradation). The degraded product peaks were well resolved from the pure drug peak. The method was successfully validated as per the ICH guidelines. The developed RP-HPLC method was successfully applied for the estimation of THP and RSP in tablet dosage form.

scholarly journals Formulation, Development and Evaluation of Uncoated Bilayer Tablet of Anti-Hypertensive Agents

2020 ◽  
Vol 10 (4-s) ◽  
pp. 100-107
Author(s):  
Kunjan Gandhi ◽  
Sunil Kumar Shah ◽  
C K Tyagi ◽  
Prabhakar Budholiya ◽  
Harish Pandey
Keyword(s):  
Drug Delivery ◽  
Drug Delivery System ◽  
Delivery System ◽  
Dosage Form ◽  
Research Work ◽  
Immediate Release ◽  
Blocking Agent ◽  
Formulation Development ◽  
Bilayer Tablet ◽  
Tablet Dosage

The present research work was carried out to Formulate and evaluation of bilayer tablet dosage form for the treatment of Hypertension.The objective of this study to compare the specific characteristics of Metoprolol [beta selective (cardio selective) adrenoreceptor blocking agent] and Hydrochlorothiazide (Thiazide Diuretics]) in order to design stable formulation. It can be concluded that bilayer tablet were successfully formulated to achieve immediate release of Hydrochlorothiazide (HCTZ)  and tailored release of Metoprolol (MPL)by using Dual Release Drug Absorption System(DUREDAS technology).Both drugs were found to be stable in Bilayer tablet formulation and were found to be stable for few months. This bilayer tablet dosage form increases the stability which may reduce loss and cost of formulation. It improves the benefits of producer, retailer, and patients. Recently, greater attention has been focused on development of bilayer tablet formulations. Over the past 30 years, the expenses and complications involved in marketing new drug entities have increased with concomitant recognition of therapeutic advantages of conventional drug delivery system. Several pharmaceutical companies are currently developing bi-layer tablets, for a variety of reasons: patent extension, efficient pharmacological effect, better patient compliance, etc. Bilayer tablet is becoming new approach for the successful drug delivery system and for better stability in combination. Bilayer tablets can be primary option to avoid chemical incompatibilities between APIs by physical separation. Keywords: Bilayer tablet, DUREDAS Technology, Antihypertensive, Metoprolol, Hydrochlorthiazide

COMPATIBILITY STUDY OF ALOGLIPTIN BENZOATE WITH WIDELY USED PHARMACEUTICAL EXCIPIENTS FOR SOLID DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (02) ◽  
pp. 20-26
Author(s):  
U Nandi ◽  
◽  
M. Dahiya ◽  
A Prakash ◽  
R. Kumar ◽  
...  
Keyword(s):  
Dosage Form ◽  
Magnesium Stearate ◽  
Compatibility Study ◽  
Physical Interaction ◽  
Gravimetric Analysis ◽  
Formulation Development ◽  
Pharmaceutical Excipients ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Ft Ir

Alogliptin is a new dipeptidyl peptidase-4 (DPP-4) inhibitor for oral diabetes care. The present study aims to evaluate the compatibility of alogliptin benzoate with the extensively used pharmaceutical excipients for solid dosage form. This can be achieved by applying Differential Scanning Calorimetry (DSC) and Thermal Gravimetric Analysis (TGA) techniques together with Fourier-Transform Infrared spectroscopy (FT-IR) as paired technique to aid in the interpretation of outcome. Chosen excipients were Cross carmellose sodium, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, and pregelatinised starch. Results illustrated that drug was compatible with all the excipients except magnesium stearate where a slight degree of physical interaction was observed but mass loss due to degradation was not hastened in TGA. FT-IR study lined out any chemical change of drug with magnesium stearate. These results would be valuable for formulation development of the film coated tablets of alogliptin benzoate.

scholarly journals FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF CURCUMIN-LOADED SOLID SELF-NANOEMULSIFYING DRUG DELIVERY SYSTEM FOR COLON CARCINOMA

2019 ◽  
pp. 243-247
Author(s):  
CHENMALA KARTHIKA ◽  
RAMAN SURESHKUMAR ◽  
AMEER SUHAIL
Keyword(s):  
Drug Delivery ◽  
Colon Cancer ◽  
Drug Delivery System ◽  
Delivery System ◽  
Dosage Form ◽  
In Vitro Dissolution ◽  
Formulation Development ◽  
The World ◽  
Tablet Dosage

Objective: Cancer is the deadliest disease affecting the life of the people all around the world. Colon cancer is the cancer which is affecting the colon region it is the last part of the gastrointestinal tract which is mainly responsible for the absorption of water and minerals from the food debris. Colon cancer is the second most cancer creating death in the world. It affects both male and female equally. Curcumin is a flavonoid used from decades for the treatment of various ailments including cancer. This present work is to formulate Self-nanoemulsifying drug delivery (SNEDDS) system with the help of curcumin for colon delivery. Materials and Methods: Nanoemulsion was prepared using the curcumin pre-concentrated self-nanoemulsifying drug delivery system, with which tablets were prepared and coated with pectin followed by the evaluation test such as in vitro dissolution and cell line studies. Results: Solubility profile of curcumin was found with a greater impact using Capmul MCM and Labrafac PG which is then added with the surfactants and co-surfactants and were converted into Nano-droplets. F1 formulation was selected after carrying out the characterisation studies and converted into a tablet dosage form and then coated with pectin, in vitro studies depicted a release of 80% in pH 6.8. Conclusions: Formulation of a solid self-Nano emulsifying drug delivery system using curcumin was successfully carried out. From the results obtained, the formulation (F1) was selected for the formation of the tablets and the further experimental part is carried out. The tablet dosage form is then coated with pectin and used for targeting the colon cancer cells for its treatment.

Formulation development of an oral dosage form for an hiv protease inhibitor, AG1284

1995 ◽  
Vol 117 (2) ◽  
pp. 197-207 ◽  
Author(s):  
Chin-Chih Chiang ◽  
Mark Longer ◽  
Praveen Tyle ◽  
Dean Fessler ◽  
Bhasker Shetty
Keyword(s):  
Protease Inhibitor ◽  
Dosage Form ◽  
Hiv Protease ◽  
Oral Dosage ◽  
Formulation Development ◽  
Hiv Protease Inhibitor ◽  
Oral Dosage Form

scholarly journals Formulation development of patient friendly dosage form for eye drug delivery: Kajal

2018 ◽  
Vol 7 (SP6) ◽  
pp. 31-34
Author(s):  
Sandeep Waghulde ◽  
Archana Pawar ◽  
Minal Kadav ◽  
Pratiksha Khade ◽  
Mohan Kale
Keyword(s):  
Drug Delivery ◽  
Dosage Form ◽  
Formulation Development

scholarly journals Formulation Development of a Patient Friendly Dosage Form for Eye Drug Delivery: Kajal

Proceedings ◽  
2018 ◽  
Vol 9 (1) ◽  
pp. 69
Author(s):  
Sandeep Waghulde ◽  
Archana Pawar ◽  
Minal Kadav ◽  
Pratiksha Khade ◽  
Mohan Kale ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Medicinal Plants ◽  
Dosage Form ◽  
Ocular Delivery ◽  
Formulation Development ◽  
Rosa Rubiginosa ◽  
Antimicrobial Potential ◽  
Physiochemical Parameters ◽  
Innovative Technique

Traditionally, kajal is known as kohl or surma and is used as eyeliner. Designing herbal kajal with medicinal plants as a cosmetics product is considered to bea novel, innovative technique. The main advantages of such a product are that it is patient friendly, water resistant, stable, and economical to formulate. Two medicinal plants, viz., Rosa rubiginosa and Triphala, were evaluated for their potential for sustained ocular delivery with the aim of formulating herbal kajal. Standardization of the herbs was performed based on different physiochemical parameters, and the obtained values were within the prescribed limits. On the basis of the selected parameters and its antimicrobial potential, herbal kajal was evaluated in comparison with comparable products.

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