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Testosterone Replacement, Low T, HCG, & Beyond
When Testosterone Is Not Enough
Stability of an extemporaneously prepared tadalafil suspension
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<blockquote data-quote="madman" data-source="post: 144287" data-attributes="member: 13851"><p>A tadalafil suspension can be extemporaneously compounded from tadalafil tablets; <strong>however, there are currently no data on the <span style="color: rgb(184, 49, 47)">stability </span><span style="color: rgb(0, 0, 0)">of a</span><span style="color: rgb(184, 49, 47)"> liquid formulation.</span></strong> <strong>The objective of this study was to assess the <span style="color: rgb(184, 49, 47)">physical and chemical stability </span>of a <span style="color: rgb(184, 49, 47)">tadalafil suspension</span> over <span style="color: rgb(184, 49, 47)">91 days</span> when stored at <span style="color: rgb(184, 49, 47)">room temperature. </span></strong></p><p></p><p></p><p></p><p></p><p></p><p><strong><span style="color: rgb(41, 105, 176)">Purpose. </span></strong>The stability of an extemporaneously prepared tadalafil oral suspension was studied.</p><p></p><p><strong><span style="color: rgb(41, 105, 176)">Methods.</span></strong> <strong>An <span style="color: rgb(184, 49, 47)">oral suspension </span>of <span style="color: rgb(184, 49, 47)">tadalafil 5 mg/mL </span>was prepared by thoroughly grinding <span style="color: rgb(0, 0, 0)">15 </span><span style="color: rgb(184, 49, 47)">20 mg</span> <span style="color: rgb(184, 49, 47)">tadalafil tablets</span> in a glass mortar. <span style="color: rgb(184, 49, 47)">Thirty milliliters of Ora-Plus </span>and <span style="color: rgb(184, 49, 47)">30 mL of Ora-Sweet </span>were mixed and added to the powder to make a final volume of 60 mL.</strong> Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored at room temperature (23–25 °C). A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and at 7, 14, 28, 57, and 91 days. After double dilution (1:10 and 0.1:5 v/v) to an expected concentration of 10 mg/mL with methanol and mobile phase, respectively, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and evaluated for pH changes on each day of analysis. Taste evaluation was performed at the beginning and end of the study. Stability was defined as the retention of at least 90% of the initial concentration.</p><p></p><p><span style="color: rgb(41, 105, 176)"><strong>Results.</strong> </span><strong>At least <span style="color: rgb(184, 49, 47)">99%</span> of the initial <span style="color: rgb(184, 49, 47)">tadalafil concentration </span>remained throughout the <span style="color: rgb(184, 49, 47)">91-day </span>study period.</strong> There were no detectable changes in color, odor, taste, and pH, and no visible microbial growth was observed in any sample.</p><p></p><p><strong><span style="color: rgb(41, 105, 176)">Conclusion.</span> An <span style="color: rgb(0, 0, 0)">extemporaneously prepared </span><span style="color: rgb(184, 49, 47)">suspension</span> of <span style="color: rgb(184, 49, 47)">tadalafil 5 mg/mL</span> in a <span style="color: rgb(184, 49, 47)">1:1 mixture</span> of <span style="color: rgb(184, 49, 47)">Ora-Plus</span> and <span style="color: rgb(184, 49, 47)">Ora-Sweet </span>was stable for at least <span style="color: rgb(184, 49, 47)">91 days</span> when stored in <span style="color: rgb(184, 49, 47)">amber plastic bottles </span>at <span style="color: rgb(184, 49, 47)">room temperature. </span></strong></p></blockquote><p></p>
[QUOTE="madman, post: 144287, member: 13851"] A tadalafil suspension can be extemporaneously compounded from tadalafil tablets; [B]however, there are currently no data on the [COLOR=rgb(184, 49, 47)]stability [/COLOR][COLOR=rgb(0, 0, 0)]of a[/COLOR][COLOR=rgb(184, 49, 47)] liquid formulation.[/COLOR][/B] [B]The objective of this study was to assess the [COLOR=rgb(184, 49, 47)]physical and chemical stability [/COLOR]of a [COLOR=rgb(184, 49, 47)]tadalafil suspension[/COLOR] over [COLOR=rgb(184, 49, 47)]91 days[/COLOR] when stored at [COLOR=rgb(184, 49, 47)]room temperature. [/COLOR][/B] [B][COLOR=rgb(41, 105, 176)]Purpose. [/COLOR][/B]The stability of an extemporaneously prepared tadalafil oral suspension was studied. [B][COLOR=rgb(41, 105, 176)]Methods.[/COLOR][/B] [B]An [COLOR=rgb(184, 49, 47)]oral suspension [/COLOR]of [COLOR=rgb(184, 49, 47)]tadalafil 5 mg/mL [/COLOR]was prepared by thoroughly grinding [COLOR=rgb(0, 0, 0)]15 [/COLOR][COLOR=rgb(184, 49, 47)]20 mg[/COLOR] [COLOR=rgb(184, 49, 47)]tadalafil tablets[/COLOR] in a glass mortar. [COLOR=rgb(184, 49, 47)]Thirty milliliters of Ora-Plus [/COLOR]and [COLOR=rgb(184, 49, 47)]30 mL of Ora-Sweet [/COLOR]were mixed and added to the powder to make a final volume of 60 mL.[/B] Three identical samples of the formulation were prepared and placed in 2-oz amber plastic bottles with child-resistant caps and stored at room temperature (23–25 °C). A 1-mL sample was withdrawn from each of the three bottles with a micropipette immediately after preparation and at 7, 14, 28, 57, and 91 days. After double dilution (1:10 and 0.1:5 v/v) to an expected concentration of 10 mg/mL with methanol and mobile phase, respectively, the samples were assayed in duplicate using stability-indicating high-performance liquid chromatography. The samples were visually examined for any color change and evaluated for pH changes on each day of analysis. Taste evaluation was performed at the beginning and end of the study. Stability was defined as the retention of at least 90% of the initial concentration. [COLOR=rgb(41, 105, 176)][B]Results.[/B] [/COLOR][B]At least [COLOR=rgb(184, 49, 47)]99%[/COLOR] of the initial [COLOR=rgb(184, 49, 47)]tadalafil concentration [/COLOR]remained throughout the [COLOR=rgb(184, 49, 47)]91-day [/COLOR]study period.[/B] There were no detectable changes in color, odor, taste, and pH, and no visible microbial growth was observed in any sample. [B][COLOR=rgb(41, 105, 176)]Conclusion.[/COLOR] An [COLOR=rgb(0, 0, 0)]extemporaneously prepared [/COLOR][COLOR=rgb(184, 49, 47)]suspension[/COLOR] of [COLOR=rgb(184, 49, 47)]tadalafil 5 mg/mL[/COLOR] in a [COLOR=rgb(184, 49, 47)]1:1 mixture[/COLOR] of [COLOR=rgb(184, 49, 47)]Ora-Plus[/COLOR] and [COLOR=rgb(184, 49, 47)]Ora-Sweet [/COLOR]was stable for at least [COLOR=rgb(184, 49, 47)]91 days[/COLOR] when stored in [COLOR=rgb(184, 49, 47)]amber plastic bottles [/COLOR]at [COLOR=rgb(184, 49, 47)]room temperature. [/COLOR][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
When Testosterone Is Not Enough
Stability of an extemporaneously prepared tadalafil suspension
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