Difficulty Swallowing / Dysphagia Support
TrocheSublingualNon sterile Rx only

Buprenorphine Compounded Sublingual Troche (Dissolving Lozenge)

Troche Formulation

Buprenorphine made into a custom strength troche that dissolves 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

  • Dissolves under the tongue
  • Strength set by the prescriber
  • Dose steps between tablet sizes
  • Dye free and flavor options on request
  • Non sterile preparation

How It Works

What is 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 white tablets are 2 mg and 8 mg [1].

No FDA label describes a buprenorphine troche. A compounded troche is not FDA approved, and the FDA has not reviewed it.

What is a troche?

A troche is a small, firm lozenge that dissolves in the mouth. The pharmacy presses or molds it to the prescriber's order, so the strength can be set to the dose. For this formula, it is placed under the tongue.

What a troche gives a prescriber

  • A strength chosen to fit the plan, including steps between 2 mg and 8 mg
  • A choice of base, flavor, and dye made with the pharmacist
  • A solid dose with no liquid to measure

A troche has no added water, so it can have a longer shelf life than a liquid. The USP 795 default for a nonaqueous dosage form is up to 180 days [2]. The pharmacist sets the date for each prescription.

For prescribers

  • Addiction medicine, psychiatry, pain management, palliative care, and primary care prescribers (MD, DO, NP, PA)
  • Send the strength, the quantity, and any flavor or dye needs. Call (909) 378-7301 to talk with our pharmacist
  • Schedule III prescriptions follow federal and California controlled substance rules

For patients and caregivers

  • The labeled tablets are held under the tongue until they dissolve, and not chewed or swallowed [1]. Follow your prescriber's directions for the troche
  • Wait at least one hour before brushing your teeth, and see your dentist regularly [1]
  • Keep it away from children

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 directs the tablet to be held under the tongue until it dissolves [1].
  • The FDA has not reviewed a compounded buprenorphine troche.

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 comes in two strengths [1]. A prescriber may order a troche at a strength between them, or with a different flavor or without a certain ingredient.

Dosage forms and strengths

  • Strength per troche set by the prescriber
  • Base chosen with the pharmacist, with flavor, sugar free, or dye free options
  • Quantities matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this troche 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 warns about liver problems, precipitated withdrawal, QTc prolongation, low blood pressure on standing, and adrenal insufficiency. It contraindicates known hypersensitivity [1].

The label reports dental caries, some severe, with transmucosal buprenorphine. It advises regular dental care, rinsing 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 troche. 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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