Sildenafil Slow Release (SR) Empower?

[JakeH]

I have been buying Sildenafil SR 36mg from Empower, and the SR part is confusing. The label says take 30-60 min before sex, but it is a slow release. In practice, it still may not work in 30-60 minutes if you open the capsule.

I wrote and called Empower to ask if the capsule, ingredient or both are slow release. They have not returned either.

I wrote Defy since I purchase from them, and they said it is the capsule that is SR, and it takes 8-12 hours. When I asked how one should dose it if the label says 30-60 minutes before sex, but the SR is up to 12 hours? No response to that email.

I ran a bit of an experiment: the capsule takes 3 hours to break down in water and 35 minutes to breakdown in white vinegar. A Viagra tablet takes 3 minutes in water.

So, does anyone have insight?

(See Jason Bruce's great response below.)

 

[Vince]

Are you not able to use Tadalafil (Cialis)? I wonder why they make a slow release Sildenafil unless someone is not able to use Cialis.

 

[Vince Carter]

Viagra while its the best for me personally is already hard to use without this factor, I'd like to hear what they say about it.

 

[captain]

They have Tadalafil SR as well. I asked the Dr. what that means and we still don't really know as Tadalafil last a long time anyway. The SR effects seem to be stronger at 24 hrs than it is the day I take it. The SR don't seem to be as effective as the Sublingual Troche to me.

 

[JakeH]

Are you not able to use Tadalafil (Cialis)? I wonder why they make a slow release Sildenafil unless someone is not able to use Cialis.

Cialis does work for me, but never as good as Sildenafil. So, timing becomes an issue, as noted by most.

 

[JakeH]

Viagra while its the best for me personally is already hard to use without this factor, I'd like to hear what they say about it.

I will keep sending inquiries. I was hoping a Defy rep or Empower rep would chime in.

 

[JakeH]

They have Tadalafil SR as well. I asked the Dr. what that means and we still don't really know as Tadalafil last a long time anyway. The SR effects seem to be stronger at 24 hrs than it is the day I take it. The SR don't seem to be as effective as the Sublingual Troche to me.

This has been my experience. the 3mg is NOT SR, and it hits me in 20 minutes. The 7mg is SR, and it can take 2-6 hours to hit me.

 

[Nelson Vergel]

Here you go:

Ed Drugs Troches and Capsules- Recommendations

 

[JakeH]

Here you go:

Ed Drugs Troches and Capsules- Recommendations

I do not mean to be dense, but that only confuses the matter more. Compare SR capsules to oral dissolvable tablets. One is sustained release and the other fast acting, yet both say take 60 min prior:

Capsules:
Benefits: Capable of sustained release, which alters the pharmacokinetics of the medication by slowing metabolism to lengthen duration of action.

Sildenafil SR
Dosage form: Sustained Release Capsule
Dose: Take 1 capsule 60min prior to sex.

Oral Dissolvable Tablets (ODT)
Anecdotal Benefits: Faster onset of medication has been reported.

Sildenafil
Dosage form: ODT
Dose: Place 1 tablet under tongue and dissolve sublingually 60min prior to sex.

 

[Jasen Bruce]

Sustained release PDE-5 capsules are still commonly prescribed to be taken 60 min prior to sex.

The reason that compounding pharmacies compound PDE-5 inhibitor capsules as a sustained release is because they cannot make a tablet or capsule that is too close to the commercial equivalent. In order to justify compounding a generic, there must be at least one change from commercial product, usually the change is in dosage form, strength, and/or ingredient combination. By adding a sustained release to sildenafil capsules they are essentially creating a new product that is not available commercially.

Methylcellulose is added to to the sildenafil capsule to provide the "sustained release". It does this by binding the powder together which slows the ingredient break down, dispersion, and absorption in the gut immediately after ingestion. Although there are no studies on the pharmacokinetics of SR sildenafil capsules vs immediate release tablets, most patients respond to the higher dosage of sildenafil SR capsules within one hour of taking it (100mg+). The SR does not prevent the ingredients from being absorbed immediately, instead it just slows down the overall metabolism of the drug with the intention of extending its duration. There is no way of knowing how individuals respond since even dissolution tests do not represent the individual person's metabolism. Vinegar is not a valid test itself since you do not know how the active/inactive ingredients react with vinegar (independent of body fluids) which can alter the results.

Since you are on a lower dose (36mg) than commonly prescribed, this might be the reason for your response.

If you are looking for a compounded PDE-5 that is not sustained release, have your doctor prescribe a sublingual troche or oral dissolvable tablet (ODT). Both contain just sildenafil with no methycellulose. Both the troche and ODT can also be taken orally and they should metabolize the same as a tablet, possibly faster since the body does not have to break down the hard tablet.

I work with urologists who prescribe thousands of compounded PDE-5 inhibitors through Empower and all have their patients take 60 min prior to sex with positive outcomes, less the statistically consistent few that do not respond to PDE5 in general.

 

[JakeH]

Methylcellulose is added to to the sildenafil capsule to provide the "sustained release". It does this by binding the powder together which prevents it from breaking down, dispersing, and absorbing in the gut immediately after ingestion. Although there are no studies on the pharmacokinetics of SR sildenafil capsules vs immediate release tablets, most patients respond to the higher dosage of sildenafil SR capsules within one hour of taking it (100mg+). The SR does not prevent the ingredients from being absorbed immediately, instead it just slows down the overall metabolism of the drug with the intention of extending its duration. There is no way of knowing how individuals respond since even dissolution tests do not represent the individual person's metabolism. Vinegar is not a valid test itself since you do not know how the active/inactive ingredients react with vinegar (independent of body fluids) which can alter the results.


.

Thank you so much. The bolded section is what I needed to know. I was trying to get around the capsule being SR by separating the two parts and ingesting the powder, but noticed I still responded differently at 36mg SR than I did at 25mg Viagra. Now I know why, and I will up my dose to account for the SR IF I need action within 60 minutes. That being said, the Sildenafil SR tablets rock for me if I take them before sleep, because they last well into the next morning, versus the 4-6 hour window of Viagra.

Thanks again for the clarification.

 

[Jasen Bruce]

No problem Jake, hope I was able to help.
Do not hesitate to post any more questions as this can also help others who might encounter the same issue.

Empower will be launching their ODT tablets in roughly two weeks. In the meantime, ask Defy to order you sildenafil 100mg troches which can be broken into smaller dosages if needed as they are scored. You do not necessarily have to take the troche sublingually, it can be swallowed like a tablet and the absorption should be the same as a regular tablet, possibly faster (as reported by some patients)

 

[Dr Justin Saya MD]

sustained release pde-5 capsules are still commonly prescribed to be taken 60 min prior to sex.

The reason that compounding pharmacies compound pde-5 inhibitor capsules as a sustained release is because they cannot make a tablet or capsule that is too close to the commercial equivalent. In order to justify compounding a generic, there must be at least one change from commercial product, usually the change is in dosage form, strength, and/or ingredient combination. By adding a sustained release to sildenafil capsules they are essentially creating a new product that is not available commercially.

Methylcellulose is added to to the sildenafil capsule to provide the "sustained release". It does this by binding the powder together which slows the ingredient break down, dispersion, and absorption in the gut immediately after ingestion. Although there are no studies on the pharmacokinetics of sr sildenafil capsules vs immediate release tablets, most patients respond to the higher dosage of sildenafil sr capsules within one hour of taking it (100mg+). The sr does not prevent the ingredients from being absorbed immediately, instead it just slows down the overall metabolism of the drug with the intention of extending its duration. There is no way of knowing how individuals respond since even dissolution tests do not represent the individual person's metabolism. Vinegar is not a valid test itself since you do not know how the active/inactive ingredients react with vinegar (independent of body fluids) which can alter the results.

Since you are on a lower dose (36mg) than commonly prescribed, this might be the reason for your response.

If you are looking for a compounded pde-5 that is not sustained release, have your doctor prescribe a sublingual troche or oral dissolvable tablet (odt). Both contain just sildenafil with no methycellulose. Both the troche and odt can also be taken orally and they should metabolize the same as a tablet, possibly faster since the body does not have to break down the hard tablet.

I work with urologists who prescribe thousands of compounded pde-5 inhibitors through empower and all have their patients take 60 min prior to sex with positive outcomes, less the statistically consistent few that do not respond to pde5 in general.

excellent explanation!