Compatibility Study Between Naproxen and Tablet Excipients Using Differential Scanning Calorimetry

Botha, Shani; Lötter, A. P.

doi:10.3109/03639049009104410

Cited by 61 publications

(29 citation statements)

References 9 publications

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“…Some of the reported methods have poor predictive values and few of them are labor intensive and time consuming. For example, differential scanning calorimeter (DSC) has been proposed as a rapid method for evaluating the drug-excipient interaction [1][2][3][4][5][6]. Though it has certain advantages, such as requirement of small sample size and fast results, there are certain limitations also.…”

Section: Introductionmentioning

confidence: 99%

Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations

Verma

Garg

2004

Journal of Pharmaceutical and Biomedical Analysis

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Section: Introductionmentioning

confidence: 99%

Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations

Verma

Garg

2004

Journal of Pharmaceutical and Biomedical Analysis

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“…The reaction was accelerated with increasing temperature; it degraded at 40 °C after 1 day; but at 30 °C, no significant interaction was observed for up to 80 days. In another study, ketoprofen was found to form a eutectic mixture with magnesium stearate [40,41]. Besides, the magnesium stearate itself also reacts with APIs, and a few examples are given in the following passage.…”

Section: Potential Interactions With Impurities (Mgo)mentioning

confidence: 99%

Lubricants in Pharmaceutical Solid Dosage Forms

2014

Lubricants

182

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Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. Then, the application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of its hydration state (anhydrate, monohydrate, dihydrate, and trihydrate) and its powder characteristics on lubrication efficiency, as well as product and process performance is summarized. In addition, the impact of lubrication on the dynamics of compaction/compression processes and on the mechanical properties of compacts/tablets is presented. Furthermore, the online monitoring of magnesium stearate in a blending process is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical ingredient (API) with magnesium stearate and its reactive impurities is reviewed with examples from the literature illustrating the various reaction mechanisms involved.

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“…Moxifloxacin Hydrochloride in the excipient blend exhibited apeak at 250.2°C (Fig.4) Miniscule changes were observed in the peak temperature. Slight changes in the melting endotherm of the drug could be due to the mixing of the drug and excipients, and may not necessarily indicate potential incompatibility 18,19,20 .…”

Section: Fig 2: Ftir Spectrum Of Moxifloxacin Hydrochloride With Commentioning

confidence: 99%

Untitled

2016

IJPSR

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Human eye is a challenging subject for topical administration of the drugs because of its peculiar anatomical arrangements of surface tissue and impermeability of the cornea. Topical instillation of drugs through eye drops is the most important and wellaccepted route of administration for the treatment of various eye disorders. Conventional ophthalmic drug delivery systems often result in poor bioavailability and therefore poor therapeutic response. Several new preparations have been developed to prolong the contact time of the medicament on the ocular surface. Successful results have been obtained with inserts and collagen shields. However, these preparations have some disadvantages, such as poor patient compliance, especially by geriatric patients. This problem can be overcome by using in situ gel forming systems of polymers that exhibit reversible phase transition. Such system can be formulated as eye drops suitable for administration by instillation into the eye, which upon exposure to the eye converts to the gel phase. The advantage of these formulations is that unlike inserts and films they do not require sophisticated equipments for manufacture and they are easily scalable. The objective of the present study was to develop an ion activated in situ gelling system for Moxifloxacin Hydrochloride, so as to increase the precorneal residence time, reduced dosing frequency and improved patient compliance. In situ gel forming solution of Moxifloxacin Hydrochloride was developed using Sodium Alginate (Keltone LVCR, Protanal®) as the gelling agent in combination with Hydroxypropyl Methylcellulose (HPMC)-Methocel E50LV which acted as a viscosity-enhancing agent. The prepared formulations were evaluated for pH , gelling capacity, drug content, in vitro diffusion studies, ex vivo diffusion studies, bioadhesion test, sterility and antimicrobial efficacy studies. Key Findings: The rheological behaviors of all formulations consisting of gelling polymer were not found to be affected by the incorporation of drug and sterilization. The developed formulation providedabout90% in vitro release and 85% ex-vivo release in 12 hours. Results of the present study indicate that Moxifloxacin Hydrochloride retained its antimicrobial efficacy when formulated as an in situ gelling system. Conclusion: In situ gel forming solutions developed for Moxifloxacin Hydrochloride using polymers like Sodium alginate and HPMC prolong the release and reduce dosing frequency of the drug. Thus, the developed in situ gel forming solution is an effective alternative for conventional ophthalmic drug delivery systems.

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Compatibility Study Between Naproxen and Tablet Excipients Using Differential Scanning Calorimetry

Cited by 61 publications

References 9 publications

Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations

Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations

Lubricants in Pharmaceutical Solid Dosage Forms

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