AIM Clinical Workflow — Provider Guide

Advanced Intranasal Medium (AIM) — 50 mL Vial

AIM Delivery Protocol for Licensed Physician Use Only

Product Overview

AIM is a non-Newtonian intranasal compounding medium engineered to deliver APIs directly to the CNS via the nasal mucosa. It behaves as a viscous gel at rest (retaining API at mucosal contact) and transitions to liquid under shear (enabling precise atomization). AIM contains distilled water, vitamin E, and sodium ascorbate—providing an antioxidant, naturally antimicrobial environment.

Classification: Non-sterile compounding medium for topical intranasal use.

50 mL Vial Yield

Required Materials

• AIM 50 mL vial
• Sterile Luer-lock syringes (1 mL and 3 mL)
• 18-gauge or larger needles (required due to AIM viscosity)
• Sterile syringe coupler (Luer-lock to Luer-lock)
• Luer-lock nasal mucosa atomizer (Teleflex MAD or equivalent)
• Alcohol swabs
• Sterile gloves and clean work surface
• API preparation(s): aqueous solution(s) or lyophilized vial(s)
• USP purified water (for aqueous API dilution if needed)
• Sharps container
• Patient labels (date, API, dose, initials)

Workflow A: Aqueous API — Point-of-Care Dosing (Two-Syringe Method)

Standard AIM preparation method for in-office administration or physician-directed take-home protocols. AIM and aqueous API are combined at time of delivery using a syringe coupler.

Step 1 — Prepare Work Area

• Clean surface with 70% isopropyl alcohol
• Don sterile gloves; gather all materials

Step 2 — Draw AIM

• Swab AIM vial stopper with alcohol; allow to air-dry
• Using 1 mL Luer-lock syringe with 18 g needle, draw exactly 0.25 mL AIM
• Remove needle; set syringe aside on sterile field

Step 3 — Draw Aqueous API

• In a second 1 mL syringe, draw physician-determined API solution(s)
• Add USP purified water to bring total volume to exactly 0.25 mL
• Multiple aqueous APIs may be combined in this syringe if total volume ≤ 0.25 mL

Step 4 — Combine via Syringe Coupler

• Attach syringe coupler to both filled syringes (Luer-lock to Luer-lock)
• Gently depress plungers back and forth 5–6 times to thoroughly mix
• Draw entire 0.50 mL combined volume into one syringe
• Remove coupler; attach Luer-lock nasal atomizer

Step 5 — Administer

• Deliver 0.25 mL into first nostril (half the syringe volume)
• Deliver remaining 0.25 mL into second nostril
• Total dose delivered: 0.50 mL (0.25 mL per nostril)

Workflow B: Lyophilized API — Vial Reconstitution for Take-Home Use

For lyophilized API vials prepared for physician-directed take-home use. AIM is injected directly into the API vial for reconstitution.

Step 1 — Prepare & Label

• Label lyophilized API vial: peptide name, vial weight (mg), reconstitution volume, date, initials
• Swab self-healing vial stopper with alcohol; allow to air-dry completely
• Do not touch stopper surface after swabbing

Step 2 — Draw AIM

• Using 3 mL Luer-lock syringe with 18 g needle, draw AIM volume per protocol (see yield table above)
• Expel air bubbles

Step 3 — Inject AIM into Vial

• Pierce stopper; advance needle to bottom of vial
• Inject AIM slowly against inner glass wall to ensure complete hydration of all lyophilized API
• Withdraw needle; immediately swab stopper again with alcohol

Step 4 — Dissolve

• Gently swirl vial until solution is clear with no visible particulates
• Do not shake (prevents foaming and API degradation)

Step 5 — Dispense to Patient

• Provide reconstituted vial with Luer-lock nasal atomizer and 1 mL syringes
• Reconstituted vial is dispensed per physician protocol. Take-home use instructions, withdrawal volume, and administration frequency are determined and communicated by the treating physician.

Suggested Physician Administration Protocol (Initial Office Visit)

Suggested Patient Communication (Physician Determines)

Sample language only — physician adapts to their clinical context: "This is an intranasal delivery vehicle for your prescribed compound. You will receive a small volume in each nostril. Hold your breath briefly during the spray. You may feel mild tingling or slight coolness at the nasal mucosa — this is normal."

Suggested In-Office Administration Steps

1. Administer first dose in-office under clinician supervision
2. Observe patient for 10 minutes post-administration
3. Walk patient through self-administration technique:
   • Drawing from vial (18 g needle required)
   • Attaching atomizer
   • Proper head tilt, breath-hold, and spray delivery
4. Confirm patient can replicate procedure independently

Suggested Post-Administration Guidance (Physician Determines)

Sample language only — physician determines timing and follow-up instructions: "Do not blow or sniff your nose for at least 5 minutes after administration. Store your vial in the refrigerator. Contact your physician if you experience persistent burning, bleeding, or unusual discomfort."

AIM Delivery Technique Reference

1. Position: Patient seated upright, head tilted back 10–15°
2. Clear passages: Gently blow nose before dosing
3. Breath-hold: Patient inhales normally, then holds breath before and during spray actuation to prevent aspiration of API into lungs
4. Atomizer placement: Insert tip ~1 cm into nostril, angled slightly away from septum
5. Delivery: Depress plunger quickly and firmly; pause 2–3 seconds before removing
6. Alternate nostrils: Deliver 0.25 mL per side
7. Post-dose: Resume normal breathing; remain still 2–3 minutes; avoid blowing nose for ≥ 5 minutes

Key Clinical Advantages of AIM

• Non-Newtonian rheology: Gel at rest (retains API at mucosa), liquid under shear (enables atomization)
• Bypasses blood–brain barrier via olfactory and trigeminal nerve pathways
• 1/7th injectable dose achieves equivalent therapeutic effect with minimal systemic exposure
• Vitamin E component soothes nasal mucosa and provides antioxidant stability
• Naturally antimicrobial — supports delivery vehicle integrity
• Non-sterile topical classification — simplified regulatory and compounding requirements
• 4,000 doses per liter at 0.25 mL per dose

Storage & Handling