A Review on Stability Studies of Pharmaceutical Products

Sultana, Sumaiyya; Mohammed, Said

doi:10.31638/ijprs.v7.i1.00003

Cited by 13 publications

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“…The effects of these changes can be characterized using DSC, TG, XPRD, FTIR and SEM [24]. Following the development of the proposed finished product, stability studies are required to ensure the quality of the product and to determine the shelf life and storage conditions [25].…”

Section: Introductionmentioning

confidence: 99%

Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

et al. 2019

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The physical and chemical characterization of the solid-state properties of drugs and excipients is fundamental for planning new formulations and developing new strategies for the treatment of diseases. Techniques such as differential scanning calorimetry, thermogravimetry, X-ray powder diffraction, Fourier transform infrared spectroscopy, and scanning electron microscopy are among the most commonly used techniques for these purposes. Penciclovir and lysine are individually used to treat the herpes virus. As such, the development of a formulation containing both drugs may have therapeutic potential. Solid-state characterization showed that both penciclovir and lysine were crystalline materials with melting points at 278.27 °C and 260.91 °C, respectively. Compatibility studies of penciclovir and lysine indicated a possible interaction between these substances, as evidenced by a single melting point at 253.10 °C. The compatibility of several excipients, including ethylenediaminetetraacetic acid, cetostearyl alcohol, sodium lauryl sulphate, di-tert-butyl methyl phenol, liquid petrolatum, methylparaben, nonionic wax, paraffin, propylene glycol, and propylparaben, was evaluated in ternary (penciclovir-lysine-excipient) mixtures (1:1:1, w/w/w) to determine the optimal formulation. The developed formulation was stable under accelerated and ambient conditions, which demonstrated that the interaction between penciclovir and lysine was suitable for the development of a formulation containing both drugs.

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Section: Introductionmentioning

confidence: 99%

Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

et al. 2019

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“…In the present study, stability studies were carried out at room temperature 40 ± 20 °C and 75 ± 5% RH for a specific time period up to 3 Months for selected F5 formulations. For stability study, the tablets were sealed in aluminum packaging coated inside with polyethylene & studied for various parameters 21 .…”

Section: Stability Studies Of the Optimized Formulationmentioning

confidence: 99%

Untitled

2020

IJPSR

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Cefpodoxime Proxetil is third generation, broad-spectrum Cephalosporin Antibiotic & it has an oral bioavailability of only 50% and biological half life 2 h so to improve it ' s bioavailability sustain release matrix formulation was designed. Sustained release matrix tablets of Cefpodoxime Proxetil prepared by direct compression method based on combination of natural Acacia gum & Karaya gum polymers. 3 2 full factorial designs optimization study was carried out by using Design Expert Software to find the effect of independent variables, i.e., Acacia gum (X1) and Karaya gum (X2) concentration on dependent variables i.e., Hardness & % CDR. The drug excipient mixtures were subjected to preformulation studies. The tablets were subjected to physicochemical studies, in-vitro drug release, kinetic studies and stability studies. FTIR and DSC studies shown there was no interaction between drug and polymers. Matrix tablet of Cefpodoxime Proxetil were formulated well in term of hardness 5.07 ± 0. 5.93 ± 0.03 kg/cm 2 , thickness 2.25 ± 0.1 mm to 3.33 ± 0.3 mm, weight variation were within limits. In-vitro release studies show that almost 90 % of drug was release from all the formulation were within 12 h. Formulation F5 selected as a optimized one since it showed optimum hardness & sustained drug release within 12 h in comparison to other formulation. The F5 optimized formulations were subjected to stability studies and shown there were no significant changes in drug content, physicochemical parameters and release pattern. 3 2 full factorial design optimization technique was successfully used in this research work. Developed matrix tablets of Cefpodoxime Proxetil produced a sustained and effective drug release over a prolonged time frame that led to greater therapeutic efficacy. INTRODUCTION: The oral route is the oldest and convenient route for the administration of therapeutic agents because of the low cost of therapy and ease of administration leads to a higher level of patient compliance 1 .

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“… The main purpose of stability study is to generate the stability profile of a drug product so that the prediction of the shelf life of the product can be made before launching it into the market [6].…”

Section: Objectives Of Stability Studiesmentioning

confidence: 99%

“…Where, Y o = initial potency, Y x = final potency, K o = zero order reaction, K 1 = first order reaction [6,49].…”

Section: = − /mentioning

confidence: 99%

An Approach to Drug Stability Studies and Shelf-life Determination

Tembhare

Gupta

Umekar

2019

ACRI

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The main objective of carrying out stability studies of the drug product is to establish shelf life of drug during storage. Stability of drug is defined as “The capability of a particular formulation in a specific container/closed system, to remain within its physical, chemical, microbiological, therapeutic, and toxicological specifications throughout its shelf life”. As mentioned in the International Conference on Harmonization (ICH) guideline Q1A (R2), stability studies are commonly the activity on the critical path to regulatory filing and approval. Stability studies are of different types and different methods are useful for the determination of stability like real-time stability testing, accelerated stability testing, retained sample stability testing and cyclic temperature stress testing. pH and temperature are the main factors influencing the stability of the drug. The pH-rate profile (log(k)vs pH) is the pH dependence of the specific rate constant of degradation of compounds. Forced degradation includes deterioration of new drug substances and products at more severe conditions than the accelerated conditions and it indicates the accuracy of stability-indicating methods. The different conditions applied during the forced degradation include hydrolytic, oxidation, photolytic and thermal stress etc. The techniques utilized for evaluation of stability studies can be LC-MS/MS, HPLC-DAD, HPLC-MS, HPLC-UV, HPTLC, TLC, LC-NMR etc. amongst them some techniques shows high sensitivity and resolution power to establish more effective stability-indicating method while for shelf life estimation of drugs and products the different methods mentioned are FDA’s method, the direct method, inverse method, simulation results and Garret and Carper method. Thus stability testing of pharmaceutical products inputs specific scheme in the evolution of a new drug as well as new formulation.

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A Review on Stability Studies of Pharmaceutical Products

Cited by 13 publications

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Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

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An Approach to Drug Stability Studies and Shelf-life Determination

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