Difficulty Swallowing / Dysphagia Support
Oral suspensionSublingualNon sterile Rx only

Buprenorphine Compounded Sublingual Suspension (Liquid Buprenorphine)

Oral Suspension Formulation

Buprenorphine made into a custom strength liquid taken under the tongue. FDA labels sublingual tablets. Chino, CA.

Reviewed by Linda Pungpravat, PharmD, RPh Mixwell Compounding Pharmacy, Chino, CA. Updated

  • USP <795> compliant
  • USP <800> hazardous drug lab
  • PCCA member

Clinical Advantages

  • Liquid dose measured by volume
  • Strength set by the prescriber
  • Small dose steps for tapering plans
  • Option for patients who struggle with tablets
  • Non sterile preparation

How It Works

What is sublingual buprenorphine?

Buprenorphine is an opioid and a Schedule III controlled substance. The FDA label for buprenorphine sublingual tablets lists treatment of opioid dependence, with counseling and psychosocial support. The tablets are 2 mg and 8 mg, taken once a day under the tongue [1].

The label gives a recommended dose of 16 mg per day after induction, and a usual maintenance range of 4 mg to 24 mg per day [1]. No FDA label describes a sublingual liquid made by a pharmacy. A compounded suspension is not FDA approved, and the FDA has not reviewed it.

What is a sublingual suspension?

It's a liquid held under the tongue. The medicine is spread through a liquid base, so the bottle gets shaken before each dose. The pharmacy makes it to the prescriber's order, and the dose is measured in milliliters with an oral syringe.

What a liquid gives a prescriber

  • Small dose steps. The label says to taper gradually when stopping [1]
  • A form for patients who can't hold a whole tablet under the tongue until it dissolves
  • A choice of base, flavor, and dye made with the pharmacist

A water based liquid has a short shelf life. The USP 795 default is 35 days if it's preserved and 14 days if it isn't [2]. The pharmacist sets the date for each bottle.

For prescribers

  • Addiction medicine, psychiatry, pain management, palliative care, and primary care prescribers (MD, DO, NP, PA)
  • Send the strength, the total volume, and any flavor or dye needs. Call (909) 378-7301 to talk with our pharmacist
  • The label notes the product without naloxone is preferred for induction, and that buprenorphine with naloxone is preferred for maintenance [1]

For patients and caregivers

  • Shake the bottle well, and measure each dose with the syringe we give you
  • The label says not to eat or drink until the dose is gone, and to wait at least one hour before brushing your teeth [1]
  • See your dentist regularly. Tooth decay has been reported with buprenorphine used in the mouth [1]

Clinical Details

What does the evidence show?
  • Buprenorphine sublingual tablets are FDA labeled for opioid dependence at 2 mg and 8 mg [1].
  • The label lists a usual maintenance range of 4 mg to 24 mg per day. Doses above 24 mg have not been studied in randomized trials [1].
  • The FDA has not reviewed a compounded sublingual suspension.

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

The labeled sublingual form is a tablet in two strengths [1]. A prescriber may order a liquid at a strength that fits a tapering plan, or for a patient who can't use a tablet.

Dosage forms and strengths

  • Strength per mL set by the prescriber
  • Suspending base chosen with the pharmacist, with flavor, sugar free, or dye free options
  • Volumes matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this liquid in Chino, California under USP 795 rules for non sterile preparations [2]. Our pharmacist confirms the strength and base with the prescriber and sets the beyond use date. We ship across California, including Chino Hills, Ontario, Pomona, Diamond Bar, and Rancho Cucamonga.

Safety information

The label warns of life threatening breathing problems and death, with higher risk when combined with benzodiazepines, other CNS depressants, or alcohol. It advises checking liver tests before starting. It warns about precipitated withdrawal, QTc prolongation, low blood pressure on standing, and adrenal insufficiency. Deaths have been reported in opioid naive people after a 2 mg dose. It contraindicates known hypersensitivity [1].

The label also reports dental caries, some severe, with transmucosal buprenorphine. It advises rinsing the teeth and gums with water after the dose dissolves and waiting at least one hour before brushing [1].

These warnings come from the tablet label. No FDA labeling describes this liquid. Patient selection, dosing, and monitoring are the prescriber's responsibility. Patients should talk with their own healthcare professional before using any medication.

References
  1. Buprenorphine sublingual tablets. Prescribing information. DailyMed
  2. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

  • APIs and strengths
  • Base or vehicle
  • Quantity
  • Directions for use
  • Refills
  • Allergies or dye free needs
Call (909) 378-7301 Fax (909) 378-7071

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Compounded in Chino, CA. Delivered across California.

  • Chino
  • Chino Hills
  • Ontario
  • Pomona
  • Diamond Bar
  • Rancho Cucamonga
  • Eastvale
Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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